Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (EvoPAR-BR01)
July 28, 2026 updated by: AstraZeneca
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
Study Overview
Status
Recruiting
Conditions
Detailed Description
Approximately 4680 participants will be screened to achieve approximately 788 participants randomised to study intervention.
Participants will be randomised in a 2:2:1:2 ratio to one of the following intervention groups:
- Arm 1: saruparib (AZD5305) plus camizestrant
- Arm 2: Physician's choice CDK4/6i plus physician's choice ET
- Arm 3: Physician's choice CDK4/6i plus camizestrant
- Arm 4: Saruparib (AZD5305) plus physician's choice ET
Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Study Type
Interventional
Enrollment (Estimated)
788
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Ciudad Autónoma Buenos Aires, Argentina, 1125
- Recruiting
- Research Site
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Ciudad de Buenos Aires, Argentina, 1015
- Recruiting
- Research Site
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Ciudad de Buenos Aires, Argentina, C1280AEB
- Recruiting
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Córdoba, Argentina, 5008
- Recruiting
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Rosario, Argentina, S2000KZE
- Recruiting
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Salta, Argentina, A4400EMI
- Recruiting
- Research Site
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San Miguel de Tucumán, Argentina, 4000
- Withdrawn
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Darlinghurst, Australia, 2010
- Recruiting
- Research Site
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Darlinghurst, Australia, 2139
- Recruiting
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Malvern, Australia, 3144
- Withdrawn
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Melbourne, Australia, VIC 3000
- Recruiting
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Graz, Austria, 8036
- Recruiting
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Innsbruck, Austria, 6020
- Recruiting
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Linz, Austria, 4010
- Recruiting
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Vienna, Austria, 1090
- Recruiting
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Cachoeira de Itapemirim, Brazil, 29308-055
- Recruiting
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Curitiba, Brazil, 80060-900
- Recruiting
- Research Site
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Fortaleza, Brazil, 60336-045
- Recruiting
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Goiânia, Brazil, 74000-000
- Recruiting
- Research Site
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Jaú, Brazil, 17210-120
- Recruiting
- Research Site
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Porto Alegre, Brazil, 91350-200
- Recruiting
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Ribeirão Preto, Brazil, 14049-901
- Recruiting
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Salvador, Brazil, 41253-190
- Recruiting
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São Paulo, Brazil, 03102-002
- Recruiting
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São Paulo, Brazil, 01509-900
- Recruiting
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Plovdiv, Bulgaria, 4002
- Recruiting
- Research Site
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Sofia, Bulgaria, 1527
- Recruiting
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Stara Zagora, Bulgaria, 6003
- Recruiting
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Vratsa, Bulgaria, 3000
- Withdrawn
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Toronto, Canada, M4N 3M5
- Not yet recruiting
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Not yet recruiting
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2G9
- Not yet recruiting
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Montreal, Quebec, Canada, H4A 3J1
- Not yet recruiting
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Montreal, Quebec, Canada, H3T 1E2
- Not yet recruiting
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Montreal, Quebec, Canada, H2X 0A9
- Not yet recruiting
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Not yet recruiting
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Providencia, Chile, 7500994
- Recruiting
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Recoleta, Chile, 8420391
- Recruiting
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Santiago, Chile, 8330034
- Recruiting
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Talca, Chile, 3461341
- Recruiting
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Viña del Mar, Chile, 2520000
- Recruiting
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Beijing, China, 100044
- Recruiting
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Bengbu, China, 233004
- Recruiting
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Changchun, China, 130021
- Recruiting
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Changchun, China, 130012
- Recruiting
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Changsha, China, 410008
- Recruiting
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Changsha, China, 410013
- Recruiting
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Chengdu, China, 610000
- Recruiting
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Chengdu, China, 610072
- Recruiting
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Chongqing, China, 400042
- Recruiting
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Foshan, China, 528000
- Recruiting
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Fuzhou, China, 350014
- Recruiting
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Guangzhou, China, 510060
- Recruiting
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Guangzhou, China, 510062
- Recruiting
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Guangzhou, China, 510289
- Recruiting
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Hangzhou, China, 310022
- Recruiting
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Hangzhou, China, 310016
- Recruiting
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Harbin, China, 150081
- Recruiting
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Hefei, China, 230031
- Recruiting
- Research Site
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Hohhot, China, 010017
- Withdrawn
- Research Site
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Jining, China, 272029
- Recruiting
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Kunming, China, 650118
- Not yet recruiting
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Liuzhou, China, 545006
- Recruiting
- Research Site
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Luoyang, China, 471000
- Recruiting
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Nanchang, China, 330009
- Recruiting
- Research Site
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Nanchang, China, 330006
- Withdrawn
- Research Site
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Nanjing, China, 210029
- Recruiting
- Research Site
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Shandong, China, 250117
- Recruiting
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Shanghai, China, 200025
- Recruiting
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Shanghai, China, 200120
- Recruiting
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Shenyang, China, 110016
- Recruiting
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Shijiazhuang, China, 050000
- Recruiting
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Tianjin, China, 300000
- Recruiting
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Weifang, China, 261000
- Recruiting
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Wuhan, China, 430030
- Recruiting
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Wuhan, China, 430079
- Recruiting
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Wuhan, China, 430040
- Recruiting
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Xi'an, China, 710061
- Recruiting
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Xi'an, China, 710006
- Recruiting
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Xiamen, China, 361003
- Recruiting
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Xiangyang, China, 441000
- Recruiting
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Xinxiang, China, 453100
- Recruiting
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Zhengzhou, China, 450008
- Recruiting
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Brno, Czechia, 656 53
- Recruiting
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Hořovice, Czechia, 26831
- Recruiting
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Hradec Králové, Czechia, 500 05
- Recruiting
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Olomouc, Czechia, 77900
- Recruiting
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Prague, Czechia, 120 00
- Recruiting
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Prague, Czechia, 180 00
- Not yet recruiting
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Angers, France, 49100
- Recruiting
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Besançon, France, 25030
- Suspended
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Lille, France, 59000
- Recruiting
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Lyon, France, 69373
- Recruiting
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Marseille, France, 13273
- Recruiting
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Paris, France, 75005
- Recruiting
- Research Site
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Rouen, France, 76021
- Recruiting
- Research Site
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Saint-Herblain, France, 44805
- Recruiting
- Research Site
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Toulouse, France, 31059
- Recruiting
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Villejuif, France, 94805
- Recruiting
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Aachen, Germany, 52074
- Recruiting
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Augsburg, Germany, 86150
- Withdrawn
- Research Site
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Berlin, Germany, 13125
- Recruiting
- Research Site
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Cologne, Germany, 50937
- Withdrawn
- Research Site
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Dessau, Germany, 06847
- Recruiting
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Düsseldorf, Germany, 40225
- Recruiting
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Erlangen, Germany, 91054
- Recruiting
- Research Site
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Göttingen, Germany, DE-37099
- Recruiting
- Research Site
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Hamburg, Germany, 20357
- Recruiting
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Hanover, Germany, 30625
- Recruiting
- Research Site
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Heidelberg, Germany, 69120
- Recruiting
- Research Site
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Kiel, Germany, 24105
- Recruiting
- Research Site
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Leipzig, Germany, 04103
- Recruiting
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Ludwigsburg, Germany, 71640
- Recruiting
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München, Germany, 81675
- Recruiting
- Research Site
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Münster, Germany, 48149
- Recruiting
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Hong Kong, Hong Kong, 150001
- Not yet recruiting
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Hong Kong, Hong Kong, 999077
- Not yet recruiting
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Budapest, Hungary, 1122
- Recruiting
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Budapest, Hungary, 1145
- Recruiting
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Budapest, Hungary, 1082
- Recruiting
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Budapest, Hungary, 1062
- Not yet recruiting
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Debrecen, Hungary, 4032
- Recruiting
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Miskolc, Hungary, 3526
- Recruiting
- Research Site
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Zalaegerszeg, Hungary, 8900
- Withdrawn
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Delhi, India, 110029
- Recruiting
- Research Site
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Kolkata, India, 700160
- Withdrawn
- Research Site
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Lucknow, India, 226003
- Withdrawn
- Research Site
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Mumbai, India, 400012
- Recruiting
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Mumbai, India, 400052
- Recruiting
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Mysuru, India, 570017
- Recruiting
- Research Site
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Nagpur, India, 440001
- Recruiting
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Nashik, India, 422002
- Recruiting
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New Delhi, India, 110085
- Recruiting
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Surat, India, 396007
- Recruiting
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Thiruvananthapuram, India, 695011
- Recruiting
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Jerusalem, Israel, 9103102
- Recruiting
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Jerusalem, Israel, 9112001
- Recruiting
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Petah Tikva, Israel, 49100
- Recruiting
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Ramat Gan, Israel, 52621
- Recruiting
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Tel Aviv, Israel, 64239
- Recruiting
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Bergamo, Italy, 24127
- Recruiting
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Bologna, Italy, 40138
- Recruiting
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Milan, Italy, 20132
- Recruiting
- Research Site
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Milan, Italy, 20141
- Recruiting
- Research Site
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Modena, Italy, 41124
- Withdrawn
- Research Site
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Naples, Italy, 80131
- Recruiting
- Research Site
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Padova, Italy, 35128
- Recruiting
- Research Site
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Reggio Emilia, Italy, 422122
- Recruiting
- Research Site
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Rome, Italy, 00168
- Recruiting
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Rozzano, Italy, 20089
- Recruiting
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Chiba, Japan, 260-8717
- Recruiting
- Research Site
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Hidaka-shi, Japan, 350-1298
- Recruiting
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Hirakata-shi, Japan, 573-1191
- Recruiting
- Research Site
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Isehara-shi, Japan, 259-1193
- Recruiting
- Research Site
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Kagoshima, Japan, 892-0833
- Recruiting
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Kashiwa, Japan, 227-8577
- Recruiting
- Research Site
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Kumamoto, Japan, 860-8556
- Recruiting
- Research Site
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Kyoto, Japan, 606-8507
- Recruiting
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Kōtoku, Japan, 135-8550
- Recruiting
- Research Site
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Matsuyama, Japan, 791-0280
- Recruiting
- Research Site
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Nagoya, Japan, 464-8681
- Recruiting
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Nagoya, Japan, 466-8560
- Recruiting
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Nagoya, Japan, 467-8602
- Recruiting
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Osaka, Japan, 541-8567
- Recruiting
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Ota-shi, Japan, 373-8550
- Recruiting
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Sapporo, Japan, 003-0804
- Recruiting
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Sendai, Japan, 980-8574
- Recruiting
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Shinagawa-ku, Japan, 142-8666
- Recruiting
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Suita-shi, Japan, 565-0871
- Recruiting
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Sunto-gun, Japan, 411-8777
- Recruiting
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Takasaki-shi, Japan, 370-0829
- Recruiting
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Tsu, Japan, 514-8507
- Recruiting
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Yokohama, Japan, 241-8515
- Recruiting
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Bandar Puncak Alam, Malaysia, 42300
- Not yet recruiting
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Johor Bahru, Malaysia, 81100
- Recruiting
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Kuala Lumpur, Malaysia, 59100
- Recruiting
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Kuala Selangor, Malaysia, 62250
- Recruiting
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Malacca, Malaysia, 75000
- Recruiting
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Bellavista, Peru, CALLAO 2
- Not yet recruiting
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Jesus Maria, Lima, Peru, LIMA 11
- Not yet recruiting
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Lima, Peru, LIMA 29
- Not yet recruiting
- Research Site
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Lima, Peru, 15036
- Not yet recruiting
- Research Site
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Biała Podlaska, Poland, 21-500
- Withdrawn
- Research Site
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Koszalin, Poland, 75-581
- Recruiting
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Lodz, Poland, 93-338
- Recruiting
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Lublin, Poland, 20-090
- Recruiting
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Poznan, Poland, 60-569
- Recruiting
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Poznan, Poland, 61-485
- Withdrawn
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Radom, Poland, 26-600
- Not yet recruiting
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Warsaw, Poland, 02-781
- Recruiting
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Coimbra, Portugal, 3000-075
- Recruiting
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Lisbon, Portugal, 1998-018
- Recruiting
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Lisbon, Portugal, 1099-023
- Recruiting
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Matosinhos Municipality, Portugal, 4454-509
- Recruiting
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Porto, Portugal, 4050-115
- Recruiting
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Vila Real, Portugal, 5000-508
- Recruiting
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San Juan, Puerto Rico, 00918
- Recruiting
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Daegu, South Korea, 41404
- Recruiting
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Seongnam-si, South Korea, 13620
- Recruiting
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Seoul, South Korea, 03080
- Recruiting
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Seoul, South Korea, 06351
- Recruiting
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Seoul, South Korea, 5505
- Recruiting
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Seoul, South Korea, 3722
- Recruiting
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Seoul, South Korea, 02841
- Recruiting
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Seoul, South Korea, 06273
- Recruiting
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A Coruña, Spain, 15009
- Not yet recruiting
- Research Site
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Barcelona, Spain, 08035
- Recruiting
- Research Site
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Cáceres, Spain, 10003
- Withdrawn
- Research Site
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Granada, Spain, 18007
- Recruiting
- Research Site
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L'Hospitalet de Llobregat, Spain, 08908
- Recruiting
- Research Site
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Madrid, Spain, 28040
- Recruiting
- Research Site
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Madrid, Spain, 28041
- Recruiting
- Research Site
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Málaga, Spain, 29010
- Recruiting
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Pamplona, Spain, 31008
- Withdrawn
- Research Site
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Seville, Spain, 41013
- Recruiting
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Valencia, Spain, 46006
- Recruiting
- Research Site
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Zaragoza, Spain, 50009
- Not yet recruiting
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New Taipei City, Taiwan, 23561
- Recruiting
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Taichung, Taiwan
- Recruiting
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Tainan, Taiwan, 704
- Recruiting
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Taipei, Taiwan, 100
- Recruiting
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Taipei, Taiwan, 112
- Recruiting
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Taipei, Taiwan, 10449
- Recruiting
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Taoyuan, Taiwan, 00333
- Recruiting
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Bangkok, Thailand, 10210
- Recruiting
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Bangkok, Thailand, 10330
- Recruiting
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Dusit, Thailand, 10300
- Terminated
- Research Site
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Hat Yai, Thailand, 90110
- Recruiting
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Muang, Thailand, 22000
- Not yet recruiting
- Research Site
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Ratchathewi, Thailand, 10400
- Not yet recruiting
- Research Site
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Ratchathewi, Thailand, 10400
- Recruiting
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Adapazarı, Turkey (Türkiye), 54290
- Recruiting
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Altındağ-Ankara, Turkey (Türkiye), 06230
- Recruiting
- Research Site
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Ankara, Turkey (Türkiye), 06530
- Not yet recruiting
- Research Site
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Istanbul, Turkey (Türkiye), 34214
- Recruiting
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Kayseri, Turkey (Türkiye), 38039
- Recruiting
- Research Site
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Çankaya, Turkey (Türkiye), 06680
- Withdrawn
- Research Site
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Cambridge, United Kingdom, CB2 2QQ
- Recruiting
- Research Site
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Guildford, United Kingdom, GU2 7XX
- Recruiting
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London, United Kingdom, SE1 9RT
- Recruiting
- Research Site
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Manchester, United Kingdom, M20 4BX
- Recruiting
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Oxford, United Kingdom, OX3 7LE
- Withdrawn
- Research Site
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Swansea, United Kingdom, SA2 8QA
- Withdrawn
- Research Site
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Taunton, United Kingdom, TA1 5DA
- Recruiting
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Truro, United Kingdom, TR1 3LJ
- Recruiting
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Arizona
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Gilbert, Arizona, United States, 85234
- Recruiting
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California
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Fountain Valley, California, United States, 92708
- Recruiting
- Research Site
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Glendale, California, United States, 91206
- Recruiting
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Los Angeles, California, United States, 90089
- Recruiting
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Newport Beach, California, United States, 92663
- Recruiting
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Research Site
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Grand Junction, Colorado, United States, 81501
- Withdrawn
- Research Site
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Florida
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Hollywood, Florida, United States, 33021
- Recruiting
- Research Site
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Jacksonville, Florida, United States, 32224
- Recruiting
- Research Site
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Orlando, Florida, United States, 32806
- Withdrawn
- Research Site
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Recruiting
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Chicago, Illinois, United States, 60611
- Recruiting
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Evanston, Illinois, United States, 60201
- Recruiting
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Park Ridge, Illinois, United States, 60068
- Withdrawn
- Research Site
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Urbana, Illinois, United States, 61801
- Recruiting
- Research Site
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Winfield, Illinois, United States, 60190
- Recruiting
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Indiana
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Indianapolis, Indiana, United States, 46227
- Withdrawn
- Research Site
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Kentucky
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Louisville, Kentucky, United States, 40207
- Withdrawn
- Research Site
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Maryland
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Baltimore, Maryland, United States, 21201
- Not yet recruiting
- Research Site
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Silver Spring, Maryland, United States, 20904
- Recruiting
- Research Site
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Silver Spring, Maryland, United States, 20902
- Withdrawn
- Research Site
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Research Site
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Michigan
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Dearborn, Michigan, United States, 48126
- Withdrawn
- Research Site
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Detroit, Michigan, United States, 48202
- Withdrawn
- Research Site
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Royal Oak, Michigan, United States, 48073
- Withdrawn
- Research Site
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Royal Oak, Michigan, United States, 48073
- Recruiting
- Research Site
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
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Missouri
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Saint Joseph, Missouri, United States, 64507
- Recruiting
- Research Site
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Springfield, Missouri, United States, 65804
- Recruiting
- Research Site
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St Louis, Missouri, United States, 63110
- Not yet recruiting
- Research Site
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New Jersey
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Camden, New Jersey, United States, 08103
- Recruiting
- Research Site
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New Brunswick, New Jersey, United States, 08901
- Withdrawn
- Research Site
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New York
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Brooklyn, New York, United States, 11220
- Withdrawn
- Research Site
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Mineola, New York, United States, 11501
- Recruiting
- Research Site
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New Hyde Park, New York, United States, 11042
- Withdrawn
- Research Site
-
New York, New York, United States, 10065
- Recruiting
- Research Site
-
New York, New York, United States, 10016
- Recruiting
- Research Site
-
New York, New York, United States, 10028
- Withdrawn
- Research Site
-
Shirley, New York, United States, 11967
- Withdrawn
- Research Site
-
Stony Brook, New York, United States, 11790
- Recruiting
- Research Site
-
The Bronx, New York, United States, 10469
- Withdrawn
- Research Site
-
Westbury, New York, United States, 11590
- Withdrawn
- Research Site
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Research Site
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Research Site
-
Pittsburgh, Pennsylvania, United States, 15212
- Not yet recruiting
- Research Site
-
Pittsburgh, Pennsylvania, United States, 15215
- Recruiting
- Research Site
-
-
South Carolina
-
West Columbia, South Carolina, United States, 29169
- Withdrawn
- Research Site
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37404
- Recruiting
- Research Site
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Research Site
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Research Site
-
Houston, Texas, United States, 77030
- Withdrawn
- Research Site
-
Houston, Texas, United States, 77054
- Recruiting
- Research Site
-
San Antonio, Texas, United States, 78240
- Recruiting
- Research Site
-
-
Virginia
-
Norfolk, Virginia, United States, 23502
- Recruiting
- Research Site
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Recruiting
- Research Site
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- Research Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Withdrawn
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
- Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
- Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
- FFPE tumour tissue from each participant
- Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
- Adequate organ and marrow function
Exclusion Criteria:
- Participants with history of MDS/AML or with features suggestive of MDS/AML
- Participants with any known predisposition to bleeding
- Any history of persisting severe cytopenia
- Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
- Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
- History of another primary malignancy
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia
- Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C
- Evidence of active and uncontrolled HIV infection
- Active tuberculosis infection
- Cardiac criteria, including history of arrythmia and cardiovascular disease
- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
- Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
- Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
- Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total before randomisation
- Prior treatment within 28 days with blood product support or growth factor support
- Any systemic concurrent anti-cancer treatment
Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
- Strong and moderate CYP3A4 inducers/inhibitors
- Sensitive CYP2B6 substrates
- Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
- Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
- Systemic use of atropine
The following exclusion criteria apply to treatments administered for early breast cancer:
- Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
- Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
- Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
- Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: saruparib (AZD5305) plus camizestrant
participants will receive saruparib (AZD5305) orally and camizestrant orally
|
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
|
|
Active Comparator: Arm 2: Physician's choice CDK4/6i plus physician's choice ET
agents are indicated below and should follow local guidelines:
|
Endocrine Therapy
CDK 4/6 Inhibitor
CDK4/6 Inhibitor
CDK4/6 Inhibitor
Endorcine Therapy
Endocrine Therapy
Endocrine Therapy
|
|
Experimental: Arm 3: Physician's choice CDK4/6i plus camizestrant
participants will receive camizestrant orally.
Agents for CDK4/6i treatment are indicated above and should follow local guidelines
|
CDK 4/6 Inhibitor
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
CDK4/6 Inhibitor
CDK4/6 Inhibitor
|
|
Experimental: Arm 4: Saruparib (AZD5305) plus physician's choice ET
participants will receive Saruparib (AZD5305) plus -Physician's Choice ET:
|
Endocrine Therapy
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Endorcine Therapy
Endocrine Therapy
Endocrine Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (Arm 1 vs arm 2)
Time Frame: Up to approximately 64 months
|
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
|
Up to approximately 64 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
|
Up to approximately 64 months
|
|
Overall Survival (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 88 months
|
OS is defined as the time from randomisation until the date of death due to any cause.
|
Up to approximately 88 months
|
|
Progression Free Survival 2 (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
|
Up to approximately 64 months
|
|
Time to chemotherapy (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
Time to chemotherapy is defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).
|
Up to approximately 64 months
|
|
Objective Response Rate (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
ORR is defined as the proportion of participants who have a complete or partial response, as determined by BICR per RECIST v1.1.
|
Up to approximately 64 months
|
|
Duration of Response (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
|
Up to approximately 64 months
|
|
Participant-reported tolerability (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
Proportion of all dosed participants reporting different levels of severity of diarrhoea as measured by the diarrhoea single item (EORTC IL237/IL239/IL240) and different levels of severity of abdominal pain as measured by the abdominal pain single item (EORTC IL237/IL239/IL240).
|
Up to approximately 64 months
|
|
Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
This scale includes 2 items asking participants to report overall health and overall quality of life in the past week.
Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent.
Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
|
Up to approximately 64 months
|
|
Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time Frame: Up to approximately 64 months
|
This scale includes 2 items asking participants to report overall health and overall quality of life in the past week.
Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent.
Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
|
Up to approximately 64 months
|
|
Plasma concentrations of saruparib (AZD5305)
Time Frame: Up to approximately 64 months
|
Up to approximately 64 months
|
|
|
Plasma concentrations of camizestrant
Time Frame: Up to approximately 64 months
|
Up to approximately 64 months
|
|
|
Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Time Frame: Up to approximately 64 months
|
Samples will be tested by a CDx to confirm BRCA1/2 and PALB2 gene mutation status
|
Up to approximately 64 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Estimated)
December 18, 2029
Study Completion (Estimated)
December 30, 2031
Study Registration Dates
First Submitted
March 25, 2024
First Submitted That Met QC Criteria
April 18, 2024
First Posted (Actual)
April 24, 2024
Study Record Updates
Last Update Posted (Actual)
July 30, 2026
Last Update Submitted That Met QC Criteria
July 28, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Breast Neoplasms
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Nitriles
- Estradiol
- Estrenes
- Estranes
- Estradiol Congeners
- Gonadal Steroid Hormones
- Gonadal Hormones
- Triazoles
- Letrozole
- Fulvestrant
- Anastrozole
- abemaciclib
- ribociclib
- palbociclib
- exemestane
- AZD5305
- AZD9833
Other Study ID Numbers
- D9722C00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles.
For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.