Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC (CAPItello-290)

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

Study Overview

• Status: Active, not recruiting
• Conditions: Triple Negative Breast Neoplasms
• Intervention / Treatment: Drug: Capivasertib; Drug: Paclitaxel; Drug: Placebo

Detailed Description

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC)

• Study Type: Interventional
• Enrollment (Actual): 923
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1012AAR
    • Research Site
  • Caba, Argentina, C1426ANZ
    • Research Site
  • Caba, Argentina, C1019ABS
    • Research Site
  • Caba, Argentina, 1414
    • Research Site
  • Ciudad Autonoma De Buenos Aire, Argentina, C1125ABD
    • Research Site
  • Ciudad Autonomade Buenos Aires, Argentina, 1426
    • Research Site
  • La Plata, Argentina, 1900
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Florianópolis, Brazil, 88034-000
    • Research Site
  • Goiania, Brazil, 74605-070
    • Research Site
  • Londrina, Brazil, 86015-520
    • Research Site
  • Natal, Brazil, 59075-740
    • Research Site
  • Porto Alegre, Brazil, 90619-900
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Rio de Janeiro, Brazil, 20560-120
    • Research Site
  • Sao Paulo, Brazil, 01317-000
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 03102-002
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • Research Site
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
      • Research Site
    • North York, Ontario, Canada, M2K 1E1
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X5
      • Research Site
• China
  • Beijing, China
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Changsha, China, 410078
    • Research Site
  • Chengdu, China, 610000
    • Research Site
  • Chengdu, China, 610072
    • Research Site
  • Foshan, China, 528000
    • Research Site
  • Guangzhou, China, 510060
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  • Guiyang, China, 550004
    • Research Site
  • Haikou, China, 570311
    • Research Site
  • Hangzhou, China, 310022
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  • Hangzhou, China, 310003
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Harbin, China, 150081
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  • Hefei, China, 230001
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  • Jinan, China, 250117
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  • Linyi, China, 276000
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  • Nanchang, China, 330009
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  • Nanjing, China, 210029
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  • Nanyang, China, 473009
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  • Shanghai, China, 200032
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  • Shenyang, China, 110001
    • Research Site
  • Shenyang, China, 110042
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  • Urumqi, China, 830000
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  • Wenzhou, China, 325000
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  • Wuhan, China
    • Research Site
  • Wuhan, China, 430030
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  • Xi'an, China, 710061
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  • Zhengzhou, China, 450000
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• Colombia
  • Floridablanca, Colombia, 681004
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  • Ibague, Colombia, 730006
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  • Medellin, Colombia, 5001000
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  • Monteria, Colombia, 23001
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  • Valledupar, Colombia, 200001
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• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Research Site
  • Jihlava, Czechia, 586 33
    • Research Site
  • Olomouc, Czechia, 77900
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  • Praha 10, Czechia, 100 34
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  • Praha 2, Czechia, 128 08
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  • Praha 4, Czechia, 140 00
    • Research Site
• France
  • Brest Cedex, France, 29609
    • Research Site
  • Lyon, France, 69008
    • Research Site
  • Marseille, France, 13009
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  • Montpellier, France, 34070
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  • Nice, France, 6189
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  • Paris, France, 75020
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  • Saint Herblain, France, 44805
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  • Villejuif, France, 94805
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• Greece
  • Athens, Greece, 11528
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  • Athens, Greece, 115 22
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  • Athens, Greece, 12462
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  • Heraklion, Greece, 711 11
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  • Thessaloniki, Greece, 54645
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• Hungary
  • Budapest, Hungary, 1106
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  • Budapest, Hungary, 1062
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  • Budapest, Hungary, 1097
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  • Győr, Hungary, 9024
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  • Nyíregyháza, Hungary, 4400
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  • Szekszárd, Hungary, 7100
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• India
  • Bangalore, India, 560052
    • Research Site
  • Bangalore, India, 560064
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  • Gurgaon, India, 122001
    • Research Site
  • Kolkata, India, 700160
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  • Kolkata, India, 700054
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  • Mumbai, India, 400012
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  • Mysuru, India, 570017
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  • Nagpur, India, 440012
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  • Nagpur, India, 440001
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  • Nashik, India, 422002
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  • New Delhi, India, 110085
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  • New Delhi, India, 11029
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• Japan
  • Bunkyo-ku, Japan, 113-8431
    • Research Site
  • Fukuoka-shi, Japan, 811-1395
    • Research Site
  • Hidaka-shi, Japan, 350-1298
    • Research Site
  • Hiroshima-shi, Japan, 730-8518
    • Research Site
  • Kagoshima-shi, Japan, 892-0833
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Research Site
  • Koto-ku, Japan, 135-8550
    • Research Site
  • Kumamoto-shi, Japan, 860-8556
    • Research Site
  • Matsuyama-shi, Japan, 791-0280
    • Research Site
  • Nagoya-shi, Japan, 464-8681
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  • Niigata-shi, Japan, 951-8566
    • Research Site
  • Osaka-shi, Japan, 541-8567
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  • Osaka-shi, Japan, 540-0006
    • Research Site
  • Ota-shi, Japan, 373-8550
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  • Sapporo-shi, Japan, 003-0804
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  • Sendai-shi, Japan, 980-8574
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  • Shinagawa-ku, Japan, 142-8666
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  • Shinjuku-ku, Japan, 162-8655
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  • Sunto-gun, Japan, 411-8777
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  • Takasaki-shi, Japan, 370-0829
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  • Tsu-shi, Japan, 514-8507
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  • Tsukuba-shi, Japan, 305-8576
    • Research Site
  • Yokohama-shi, Japan, 241-8515
    • Research Site
• Korea, Republic of
  • Busan-si, Korea, Republic of, 602-739
    • Research Site
  • Cheonan-si, Korea, Republic of, 31151
    • Research Site
  • Cheongju-si, Korea, Republic of, 28644
    • Research Site
  • Daegu, Korea, Republic of, 41404
    • Research Site
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Incheon, Korea, Republic of, 21565
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 02841
    • Research Site
  • Seoul, Korea, Republic of, 06273
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Kuala Lumpur, Malaysia, 50586
    • Research Site
  • Kuching, Malaysia, 93586
    • Research Site
  • Selangor, Malaysia, 62250
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Research Site
  • Estado de México, Mexico, 50080
    • Research Site
  • Guadalajara, Mexico, 44680
    • Research Site
  • Mexico, Mexico, 06725
    • Research Site
  • Monterrey, Mexico, 64710
    • Research Site
  • Tuxtla Gutierrez, Mexico, 29090
    • Research Site
  • Tuxtla Gutierrez, Mexico, 29038
    • Research Site
• Peru
  • Arequipa, Peru, AREQUIPA01
    • Research Site
  • Callao, Peru, CALLAO 02
    • Research Site
  • Lima, Peru, 15033
    • Research Site
  • Lima, Peru, L27
    • Research Site
  • Lima, Peru, LIMA 34
    • Research Site
  • Lima, Peru, 0051
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Research Site
  • Baguio City, Philippines, 2600
    • Research Site
  • Cagayan De Oro City, Philippines, 9000
    • Research Site
  • Cebu City, Philippines, 6000
    • Research Site
  • Davao City, Philippines, 8000
    • Research Site
  • Iloilo, Philippines, 5000
    • Research Site
  • Iloilo City, Philippines
    • Research Site
  • Las Pinas, Philippines, 1740
    • Research Site
  • Legazpi City, Philippines, 4500
    • Research Site
  • Manila, Philippines, 1000
    • Research Site
  • Quezon City, Philippines, 1112
    • Research Site
  • San Juan, Philippines, 1500
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • Research Site
  • Konin, Poland, 62-500
    • Research Site
  • Poznan, Poland, 61-866
    • Research Site
  • Racibórz, Poland, 47-400
    • Research Site
  • Radom, Poland, 26-600
    • Research Site
  • Tomaszów Mazowiecki, Poland, 97-200
    • Research Site
  • Warszawa, Poland, 01-748
    • Research Site
  • Wroclaw, Poland, 53-413
    • Research Site
• Portugal
  • Lisboa, Portugal, 1649-035
    • Research Site
  • Lisboa, Portugal, 1099-023
    • Research Site
  • Lisboa, Portugal, 1400-038
    • Research Site
  • Porto, Portugal, 4099-001
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Research Site
  • Moscow, Russian Federation, 115478
    • Research Site
  • Moscow, Russian Federation, 117997
    • Research Site
  • Moscow, Russian Federation, 121205
    • Research Site
  • Moscow, Russian Federation, 121467
    • Research Site
  • Saint-Petersburg, Russian Federation, 190103
    • Research Site
  • Saint-Petersburg, Russian Federation, 197758
    • Research Site
  • Volgograd, Russian Federation, 400138
    • Research Site
  • Yaroslavl, Russian Federation, 150054
    • Research Site
• Saudi Arabia
  • Dammam, Saudi Arabia, 31444
    • Research Site
  • Jeddah, Saudi Arabia, 22384
    • Research Site
  • Makkah, Saudi Arabia, 24246
    • Research Site
  • Riyadh, Saudi Arabia, 11426
    • Research Site
  • Riyadh, Saudi Arabia, 11525
    • Research Site
  • Riyadh, Saudi Arabia, 12713
    • Research Site
  • Riyadh, Saudi Arabia, 12311
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 833 01
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• South Africa
  • Johannesburg, South Africa, 2193
    • Research Site
  • Johannesburg, South Africa, 2196
    • Research Site
  • Pretoria, South Africa, 0002
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  • Pretoria, South Africa, 0084
    • Research Site
• Spain
  • Badalona, Spain, 08916
    • Research Site
  • Barcelona, Spain, 8035
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Hospitalet deLlobregat, Spain, 08907
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Sevilla, Spain, 41009
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Lund, Sweden, 221 85
    • Research Site
  • Stockholm, Sweden, 118 83
    • Research Site
• Taiwan
  • Hsinchu, Taiwan, 300
    • Research Site
  • Hualien City, Taiwan, 97002
    • Research Site
  • Kaohsiung, Taiwan, 82445
    • Research Site
  • Kaohsiung, Taiwan, 83301
    • Research Site
  • Tainan, Taiwan, 710
    • Research Site
  • Tainan City, Taiwan, 73657
    • Research Site
  • Taipei, Taiwan, 235
    • Research Site
  • Taipei, Taiwan, 104
    • Research Site
  • Taipei City, Taiwan, 114
    • Research Site
  • Taipei City, Taiwan, 11217
    • Research Site
• Thailand
  • Bangkok, Thailand, 10210
    • Research Site
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Mueang, Thailand, 50200
    • Research Site
• Turkey
  • Ankara, Turkey, 06100
    • Research Site
  • Ankara, Turkey, 06520
    • Research Site
  • Istanbul, Turkey
    • Research Site
  • Izmir, Turkey, 35100
    • Research Site
  • Malatya, Turkey, 44280
    • Research Site
  • Mersin, Turkey, 33070
    • Research Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Research Site
  • London, United Kingdom, NW3 2QG
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  • London, United Kingdom, E1 1BB
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  • Sheffield, United Kingdom, S10 2SJ
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  • Surrey, United Kingdom, GU2 7XX
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  • York, United Kingdom, YO31 8HE
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• United States
  • California
    • Whittier, California, United States, 90603
      • Research Site
    • Whittier, California, United States, 90602
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Research Site
    • Miami, Florida, United States, 33136
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
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    • Tampa, Florida, United States, 33612
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  • Illinois
    • Chicago, Illinois, United States, 60637
      • Research Site
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Research Site
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
  • New York
    • Nyack, New York, United States, 10960
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Research Site
    • Columbus, Ohio, United States, 43210
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  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
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    • Pittsburgh, Pennsylvania, United States, 15213
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  • Tennessee
    • Nashville, Tennessee, United States, 37203
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  • Texas
    • Austin, Texas, United States, 78758
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    • Fort Worth, Texas, United States, 76104
      • Research Site
    • Houston, Texas, United States, 77090
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    • San Antonio, Texas, United States, 78229
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  • Virginia
    • Fairfax, Virginia, United States, 22031
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• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh, Vietnam, 700000
    • Research Site
  • Ho Chi Minh city, Vietnam
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed TNBC from most recently collected tumour tissue sample
2. Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
3. ECOG/WHO PS: 0-1
4. Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease
5. FFPE tumour sample from primary/recurrent cancer

Exclusion Criteria:

1. Prior Chemotherapy in the neoadjuvant or adjuvant setting within 6 months from the end of chemotherapy to the date of randomization; taxane chemotherapy in the neoadjuvant or adjuvant setting within 12 months from the end of chemotherapy to the start of randomization
2. Prior systematic therapy for inoperable locally advanced or metastatic disease

3. Prior treatment with any of the treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions:

   • AKT, PI3K, and/or mTOR inhibitors
   • Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study)
   • Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor
   • Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to the first dose of study treatment.
4. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
5. Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
6. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment

7. Any of the following cardiac criteria at screening:

   • Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs
   • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)
   • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
   • Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2
   • Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg
   • Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiplegated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).

8. Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:

   • Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
   • HbA1c ≥8.0% (63.9 mmol/mol)
9. Inadequate bone marrow reserve or organ function at screening
10. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capivasertib + Paclitaxel; Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.	Drug: Capivasertib; 400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.; Other Names: AZD5363; Drug: Paclitaxel; 80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
Placebo Comparator: Placebo + Paclitaxel; Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.	Drug: Paclitaxel; 80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.; Drug: Placebo; Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle; Other Names: Placebo tablets to match capivasertib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival (OS)	The time from date of randomisation to the date of death due to any cause up to approximately 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1)	The time from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 42 months
Investigator assessment of PFS2	PFS2 - time from randomisation to second progression or death	Time from randomization to second progression or death due to any cause up to approximately 42 months
Response Rate (ORR)	Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1)	Up to approximately 42 months
Safety and tolerability of drugs by assessment of AEs/SAEs	Graded according to the National Cancer Institute (NCI CTCAE)	Up to approximately 42 months
Minimum plasma concentration(Cmin), plasma concentration1-2 hours post-dose (C1-2h) and 4 hours post-dose (C4h) during months 1 and 2	Plasma PK parameters derived from a population model as data permits	During months 1 and 2
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)	The self-administered instrument includes 23-items and yields 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Items are scored on a 4-point verbal rating scale: "Not at All," "A Little," "Quite a Bit," and "Very Much". Scores are transformed to a 0 to 100 scale, where higher scores indicate better unctioning, better HRQoL, or greater level of symptom.	approximately up to 42 months
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)	5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), and global health status/QoL scale, along with 5 individual item symptom scores (appetite loss, dyspnoea, insomnia, constipation, and diarrhoea. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales/scores represent greater symptom severity.	approximately up to 42 months
Duration of Response (DoR)	Duration of Response (DoR) - time from the date of first documented response until date of documented progression (as assessed by the investigator, using RECIST 1.1) or death in the absence of disease progression.	Up to approximately 42 months
Clinical Benefit Rate (CBR)	Clinical Benefit Rate (CBR) - number of patients with complete or partial response or with stable disease maintained ≥24 weeks (as assessed by the investigator, using RECIST 1.1) divided by the number of patients in the analysis	Up to approximately 42 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Peter Schmid, MD,PhD,FRCP, Centre for Experimental Cancer Medicine (CECM), Barts Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Estimated): March 18, 2024
• Study Completion (Estimated): March 18, 2024

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Triple-negative Breast Cancer; Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: D3614C00001; 2018-004687-64 (EudraCT Number)

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. All request 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 Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• 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