Saruparib (AZD5305) Plus Camizestrant 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)

May 14, 2026 updated by: AstraZeneca

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant 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

Advanced Breast Cancer

Intervention / Treatment

Detailed Description

Approximately 2,620 participants will be screened to achieve approximately 500 participants randomised to study intervention.

Participants will be randomised in a 2:2:1 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 Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Study Type

Interventional

Enrollment (Estimated)

500

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

Argentina
- - Ciudad Autónoma Buenos Aires, Argentina, 1125
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1015
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1280AEB
    - Recruiting
    - Research Site
  - Córdoba, Argentina, 5008
    - Recruiting
    - Research Site
  - Rosario, Argentina, S2000KZE
    - Recruiting
    - Research Site
  - Salta, Argentina, A4400EMI
    - Recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, 4000
    - Withdrawn
    - Research Site
Australia
- - Darlinghurst, Australia, 2010
    - Recruiting
    - Research Site
  - Darlinghurst, Australia, 2139
    - Recruiting
    - Research Site
  - Malvern, Australia, 3144
    - Withdrawn
    - Research Site
  - Melbourne, Australia, VIC 3000
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Innsbruck, Austria, 6020
    - Recruiting
    - Research Site
  - Linz, Austria, 4010
    - Recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
Brazil
- - Cachoeira de Itapemirim, Brazil, 29308-055
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80060-900
    - Recruiting
    - Research Site
  - Fortaleza, Brazil, 60336-045
    - Recruiting
    - Research Site
  - Goiânia, Brazil, 74000-000
    - Recruiting
    - Research Site
  - Jaú, Brazil, 17210-120
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Ribeirão Preto, Brazil, 14049-901
    - Recruiting
    - Research Site
  - Salvador, Brazil, 41253-190
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 03102-002
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01509-900
    - Recruiting
    - Research Site
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1527
    - Recruiting
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Recruiting
    - Research Site
  - Vratsa, Bulgaria, 3000
    - Withdrawn
    - Research Site
Canada
- - Toronto, Canada, M4N 3M5
    - Not yet recruiting
    - Research Site
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Not yet recruiting
    - Research Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2G9
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4A 3J1
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 0A9
    - Not yet recruiting
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Not yet recruiting
    - Research Site
Chile
- - Providencia, Chile, 7500994
    - Recruiting
    - Research Site
  - Recoleta, Chile, 8420391
    - Recruiting
    - Research Site
  - Santiago, Chile, 8330034
    - Recruiting
    - Research Site
  - Talca, Chile, 3461341
    - Recruiting
    - Research Site
  - Viña del Mar, Chile, 2520000
    - Recruiting
    - Research Site
China
- - Beijing, China, 100044
    - Recruiting
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Recruiting
    - Research Site
  - Changchun, China, 130012
    - Recruiting
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610000
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chongqing, China, 400042
    - Recruiting
    - Research Site
  - Foshan, China, 528000
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Recruiting
    - Research Site
  - Guangzhou, China, 510062
    - Recruiting
    - Research Site
  - Guangzhou, China, 510289
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Hangzhou, China, 310016
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230031
    - Recruiting
    - Research Site
  - Hohhot, China, 010017
    - Withdrawn
    - Research Site
  - Jining, China, 272029
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Not yet recruiting
    - Research Site
  - Liuzhou, China, 545006
    - Recruiting
    - Research Site
  - Luoyang, China, 471000
    - Recruiting
    - Research Site
  - Nanchang, China, 330009
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Withdrawn
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Shandong, China, 250117
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200120
    - Recruiting
    - Research Site
  - Shenyang, China, 110016
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 050000
    - Recruiting
    - Research Site
  - Tianjin, China, 300000
    - Recruiting
    - Research Site
  - Weifang, China, 261000
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Wuhan, China, 430079
    - Recruiting
    - Research Site
  - Wuhan, China, 430040
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xi'an, China, 710006
    - Recruiting
    - Research Site
  - Xiamen, China, 361003
    - Recruiting
    - Research Site
  - Xiangyang, China, 441000
    - Recruiting
    - Research Site
  - Xinxiang, China, 453100
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
Czechia
- - Brno, Czechia, 656 53
    - Recruiting
    - Research Site
  - Hořovice, Czechia, 26831
    - Recruiting
    - Research Site
  - Hradec Králové, Czechia, 500 05
    - Recruiting
    - Research Site
  - Olomouc, Czechia, 77900
    - Recruiting
    - Research Site
  - Prague, Czechia, 120 00
    - Recruiting
    - Research Site
  - Prague, Czechia, 180 00
    - Not yet recruiting
    - Research Site
France
- - Angers, France, 49100
    - Recruiting
    - Research Site
  - Besançon, France, 25030
    - Suspended
    - Research Site
  - Lille, France, 59000
    - Recruiting
    - Research Site
  - Lyon, France, 69373
    - Recruiting
    - Research Site
  - Marseille, France, 13273
    - Recruiting
    - Research Site
  - Paris, France, 75005
    - Recruiting
    - Research Site
  - Rouen, France, 76021
    - Recruiting
    - Research Site
  - Saint-Herblain, France, 44805
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Recruiting
    - Research Site
  - Villejuif, France, 94805
    - Recruiting
    - Research Site
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Research Site
  - Augsburg, Germany, 86150
    - Withdrawn
    - Research Site
  - Berlin, Germany, 13125
    - Recruiting
    - Research Site
  - Cologne, Germany, 50937
    - Withdrawn
    - Research Site
  - Dessau, Germany, 06847
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40225
    - Recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Recruiting
    - Research Site
  - Göttingen, Germany, DE-37099
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20357
    - Recruiting
    - Research Site
  - Hanover, Germany, 30625
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Research Site
  - Kiel, Germany, 24105
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Ludwigsburg, Germany, 71640
    - Recruiting
    - Research Site
  - München, Germany, 81675
    - Recruiting
    - Research Site
  - Münster, Germany, 48149
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong, 150001
    - Not yet recruiting
    - Research Site
  - Hong Kong, Hong Kong, 999077
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1082
    - Recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Miskolc, Hungary, 3526
    - Recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Recruiting
    - Research Site
India
- - Delhi, India, 110029
    - Recruiting
    - Research Site
  - Kolkata, India, 700160
    - Withdrawn
    - Research Site
  - Lucknow, India, 226003
    - Withdrawn
    - Research Site
  - Mumbai, India, 400012
    - Recruiting
    - Research Site
  - Mumbai, India, 400052
    - Recruiting
    - Research Site
  - Mysuru, India, 570017
    - Recruiting
    - Research Site
  - Nagpur, India, 440001
    - Recruiting
    - Research Site
  - Nashik, India, 422002
    - Recruiting
    - Research Site
  - New Delhi, India, 110085
    - Recruiting
    - Research Site
  - Surat, India, 396007
    - Recruiting
    - Research Site
  - Thiruvananthapuram, India, 695011
    - Recruiting
    - Research Site
Israel
- - Jerusalem, Israel, 9103102
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49100
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 64239
    - Recruiting
    - Research Site
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Research Site
  - Bologna, Italy, 40138
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Recruiting
    - Research Site
  - Milan, Italy, 20141
    - Recruiting
    - Research Site
  - Modena, Italy, 41124
    - Withdrawn
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Reggio Emilia, Italy, 422122
    - Recruiting
    - Research Site
  - Rome, Italy, 00168
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
Japan
- - Chiba, Japan, 260-8717
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Isehara-shi, Japan, 259-1193
    - Recruiting
    - Research Site
  - Kagoshima, Japan, 892-0833
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 227-8577
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kyoto, Japan, 606-8507
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8560
    - Recruiting
    - Research Site
  - Nagoya, Japan, 467-8602
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Ota-shi, Japan, 373-8550
    - Recruiting
    - Research Site
  - Sapporo, Japan, 003-0804
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Takasaki-shi, Japan, 370-0829
    - Recruiting
    - Research Site
  - Tsu, Japan, 514-8507
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
Malaysia
- - Bandar Puncak Alam, Malaysia, 42300
    - Not yet recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Selangor, Malaysia, 62250
    - Recruiting
    - Research Site
  - Malacca, Malaysia, 75000
    - Recruiting
    - Research Site
Peru
- - Bellavista, Peru, CALLAO 2
    - Not yet recruiting
    - Research Site
  - Jesus Maria, Lima, Peru, LIMA 11
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 29
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Not yet recruiting
    - Research Site
Poland
- - Biała Podlaska, Poland, 21-500
    - Withdrawn
    - Research Site
  - Koszalin, Poland, 75-581
    - Recruiting
    - Research Site
  - Lodz, Poland, 93-338
    - Recruiting
    - Research Site
  - Lublin, Poland, 20-090
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-569
    - Recruiting
    - Research Site
  - Poznan, Poland, 61-485
    - Withdrawn
    - Research Site
  - Radom, Poland, 26-600
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 02-781
    - Recruiting
    - Research Site
Portugal
- - Coimbra, Portugal, 3000-075
    - Recruiting
    - Research Site
  - Lisbon, Portugal, 1998-018
    - Recruiting
    - Research Site
  - Lisbon, Portugal, 1099-023
    - Recruiting
    - Research Site
  - Matosinhos Municipality, Portugal, 4454-509
    - Recruiting
    - Research Site
  - Porto, Portugal, 4050-115
    - Recruiting
    - Research Site
  - Vila Real, Portugal, 5000-508
    - Recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00918
    - Recruiting
    - Research Site
South Korea
- - Daegu, South Korea, 41404
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 3722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 02841
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06273
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15009
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Cáceres, Spain, 10003
    - Withdrawn
    - Research Site
  - Granada, Spain, 18007
    - Recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08908
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Pamplona, Spain, 31008
    - Withdrawn
    - Research Site
  - Seville, Spain, 41013
    - Recruiting
    - Research Site
  - Valencia, Spain, 46006
    - Recruiting
    - Research Site
  - Zaragoza, Spain, 50009
    - Not yet recruiting
    - Research Site
Taiwan
- - New Taipei City, Taiwan, 23561
    - Recruiting
    - Research Site
  - Taichung, Taiwan
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 100
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 00333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10210
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Dusit, Thailand, 10300
    - Terminated
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Not yet recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Not yet recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adapazarı, Turkey (Türkiye), 54290
    - Recruiting
    - Research Site
  - Altındağ-Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06530
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Research Site
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Research Site
  - Çankaya, Turkey (Türkiye), 06680
    - Withdrawn
    - Research Site
United Kingdom
- - Cambridge, United Kingdom, CB2 2QQ
    - Recruiting
    - Research Site
  - Guildford, United Kingdom, GU2 7XX
    - Recruiting
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Research Site
  - Oxford, United Kingdom, OX3 7LE
    - Withdrawn
    - Research Site
  - Swansea, United Kingdom, SA2 8QA
    - Withdrawn
    - Research Site
  - Taunton, United Kingdom, TA1 5DA
    - Recruiting
    - Research Site
  - Truro, United Kingdom, TR1 3LJ
    - Recruiting
    - Research Site
United States
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Research Site
- California
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Research Site
  - Glendale, California, United States, 91206
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90089
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
  - Grand Junction, Colorado, United States, 81501
    - Withdrawn
    - Research Site
- Florida
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32806
    - Withdrawn
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - Research Site
  - Park Ridge, Illinois, United States, 60068
    - Withdrawn
    - Research Site
  - Urbana, Illinois, United States, 61801
    - Recruiting
    - Research Site
  - Winfield, Illinois, United States, 60190
    - Recruiting
    - Research Site
- Indiana
  - Indianapolis, Indiana, United States, 46227
    - Withdrawn
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Withdrawn
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Not yet recruiting
    - Research Site
  - Silver Spring, Maryland, United States, 20904
    - Recruiting
    - Research Site
  - Silver Spring, Maryland, United States, 20902
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Withdrawn
    - Research Site
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Research Site
  - Royal Oak, Michigan, United States, 48073
    - Withdrawn
    - Research Site
  - Royal Oak, Michigan, United States, 48073
    - Recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- Missouri
  - Springfield, Missouri, United States, 65804
    - Recruiting
    - Research Site
  - St Louis, Missouri, United States, 63110
    - Not yet recruiting
    - Research Site
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Recruiting
    - Research Site
  - New Brunswick, New Jersey, United States, 08901
    - Withdrawn
    - Research Site
- New York
  - Brooklyn, New York, United States, 11220
    - Withdrawn
    - Research Site
  - Mineola, New York, United States, 11501
    - Recruiting
    - Research Site
  - 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, 15215
    - Recruiting
    - Research Site
- South Carolina
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- Tennessee
  - Chattanooga, Tennessee, United States, 37404
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  - Nashville, Tennessee, United States, 37203
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- Texas
  - Houston, Texas, United States, 77030
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  - Houston, Texas, United States, 77030
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  - Houston, Texas, United States, 77054
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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

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 up to 28 days 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:
1. Strong and moderate CYP3A4 inducers/inhibitors
2. Sensitive CYP2B6 substrates
3. 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:
1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
4. 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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: saruparib (AZD5305) plus camizestrant participants will receive saruparib (AZD5305) orally and camizestrant orally	Drug: Saruparib (AZD5305) Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2. Drug: Camizestrant 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: Physician's Choice CDK4/6i: abemaciclib orally, or ribociclib orally, or palbociclib orally. Physician's Choice ET: fulvestrant intramuscularly, or One of the following AIs: letrozole orally, or anastrozole orally, or exemestane orally	Drug: Fulvestrant Endocrine Therapy Drug: Palbociclib CDK 4/6 Inhibitor Drug: Abemaciclib CDK4/6 Inhibitor Drug: Ribociclib CDK4/6 Inhibitor Drug: Letrozole Endorcine Therapy Drug: Anastrozole Endocrine Therapy Drug: Exemestane 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	Drug: Palbociclib CDK 4/6 Inhibitor Drug: Camizestrant Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings . Drug: Abemaciclib CDK4/6 Inhibitor Drug: Ribociclib CDK4/6 Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival Time Frame: Up to approximately 59 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 59 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival 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 Time Frame: Up to approximately 59 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 59 months
Time to chemotherapy Time Frame: Up to approximately 59 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 59 months
Objective Response Rate Time Frame: Up to approximately 59 months	ORR is defined as the proportion of participants who have a complete or parial response, as determined by BICR per RECIST v1.1.	Up to approximately 59 months
Duration of Response Time Frame: Up to approximately 59 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 59 months
Participant-reported tolerability Time Frame: Up to approximately 59 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 59 months
Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Time Frame: Up to approximately 59 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 59 months
Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Time Frame: Up to approximately 59 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 59 months
Plasma concentrations of saruparib (AZD5305) Time Frame: Up to approximately 59 months		Up to approximately 59 months
Plasma concentrations of camizestrant Time Frame: Up to approximately 59 months		Up to approximately 59 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 59 months	Samples will be tested by a CDx to confirm BRCA1/2 and PALB2 gene mutation status	Up to approximately 59 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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)

March 30, 2029

Study Completion (Estimated)

October 18, 2030

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)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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