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.
2 other identifiers
interventional
923
30 countries
260
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2019
Longer than P75 for phase_3
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2026
CompletedDecember 22, 2025
December 1, 2025
6.7 years
May 20, 2019
December 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Progression-Free Survival (PFS)
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
Time from randomization to second progression or death due to any cause up to approximately 42 months
Response Rate (ORR)
Up to approximately 42 months
Safety and tolerability of drugs by assessment of AEs/SAEs
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
During months 1 and 2
- +4 more secondary outcomes
Study Arms (2)
Capivasertib + Paclitaxel
EXPERIMENTALPaclitaxel: 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.
Placebo + Paclitaxel
PLACEBO COMPARATORPaclitaxel: 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.
Interventions
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.
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: 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
Eligibility Criteria
You may qualify if:
- Histologically confirmed TNBC from most recently collected tumour tissue sample
- 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)
- ECOG/WHO PS: 0-1
- 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
- FFPE tumour sample from primary/recurrent cancer
You may not qualify if:
- 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
- Prior systematic therapy for inoperable locally advanced or metastatic disease
- 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.
- Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
- Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (260)
Research Site
Whittier, California, 90602, United States
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Whittier, California, 90603, United States
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Fort Myers, Florida, 33901, United States
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Miami, Florida, 33136, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33612, United States
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Chicago, Illinois, 60637, United States
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Westwood, Kansas, 66205, United States
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Silver Spring, Maryland, 20910, United States
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Detroit, Michigan, 48202, United States
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Nyack, New York, 10960, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43210, United States
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Harrisburg, Pennsylvania, 17109, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78758, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78229, United States
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Fairfax, Virginia, 22031, United States
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Buenos Aires, C1125ABD, Argentina
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CABA, 1414, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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CABA, C1426ANZ, Argentina
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Ciudad Autonomade Buenos Aires, 1426, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, 2000, Argentina
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Goiânia, 74605-070, Brazil
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Londrina, 86015-520, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90619-900, Brazil
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Rio de Janeiro, 20560-120, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 04014-002, Brazil
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Victoria, British Columbia, V8R 6V5, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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North York, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Beijing, 100021, China
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Beijing, China
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Changchun, 130021, China
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Changsha, 410013, China
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Changsha, 410078, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Foshan, 528000, China
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Guangzhou, 510060, China
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Guiyang, 550004, China
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Haikou, 570311, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250117, China
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Linyi, 276000, China
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Nanchang, 330009, China
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Nanjing, 210029, China
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Nanyang, 473009, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Ürümqi, 830000, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Wuhan, China
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Xi'an, 710061, China
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Zhengzhou, 450000, China
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Floridablanca, 681004, Colombia
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Ibagué, 730006, Colombia
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Medellín, 5001000, Colombia
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Montería, 23001, Colombia
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Valledupar, 200001, Colombia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Brest, 29609, France
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Lyon, 69008, France
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Marseille, 13009, France
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Montpellier, 34070, France
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Nice, 6189, France
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Paris, 75020, France
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Saint-Herblain, 44805, France
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Villejuif, 94805, France
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Athens, 115 22, Greece
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Athens, 11528, Greece
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Athens, 12462, Greece
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Heraklion, 71110, Greece
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Thessaloniki, 54645, Greece
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Budapest, 1062, Hungary
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Budapest, 1097, Hungary
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Budapest, 1106, Hungary
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Győr, 9024, Hungary
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Nyíregyháza, 4400, Hungary
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Szekszárd, 7100, Hungary
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Bangalore, 560052, India
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Bangalore, 560064, India
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Gūrgaon, 122001, India
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Kolkata, 700054, India
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Kolkata, 700160, India
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Mumbai, 400012, India
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Mysuru, 570017, India
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Nagpur, 440001, India
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Nagpur, 440012, India
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Nashik, 422002, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Bunkyō City, 113-8431, Japan
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Fukuoka, 811-1395, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Kagoshima, 892-0833, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Osaka, 540-0006, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Sunto-gun, 411-8777, Japan
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Takasaki-shi, 370-0829, Japan
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Tsu, 514-8507, Japan
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Tsukuba, 305-8576, Japan
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Yokohama, 241-8515, Japan
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Kuching, 93586, Malaysia
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Aguascalientes, 20230, Mexico
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Estado de México, 50080, Mexico
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Guadalajara, 44680, Mexico
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México, 06725, Mexico
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Monterrey, 64710, Mexico
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Tuxtla Gutiérrez, 29038, Mexico
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Tuxtla Gutiérrez, 29090, Mexico
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Arequipa, AREQUIPA01, Peru
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Callao, CALLAO 02, Peru
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Lima, 0051, Peru
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Lima, 15033, Peru
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Lima, L27, Peru
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Lima, LIMA 34, Peru
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Bacolod, 6100, Philippines
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Baguio City, 2600, Philippines
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Cagayan de Oro, 9000, Philippines
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Iloilo City, Philippines
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Las Piñas, 1740, Philippines
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Legaspi, 4500, Philippines
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Manila, 1000, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1500, Philippines
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Bydgoszcz, 85-796, Poland
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Konin, 62-500, Poland
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Poznan, 61-866, Poland
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Racibórz, 47-400, Poland
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Radom, 26-600, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 01-748, Poland
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Wroclaw, 53-413, Poland
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Lisbon, 1099-023, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Arkhangelsk, 163045, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Moscow, 121467, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 197758, Russia
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Volgograd, 400138, Russia
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Yaroslavl, 150054, Russia
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Dammam, 31444, Saudi Arabia
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Jeddah, 22384, Saudi Arabia
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Mecca, 24246, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Riyadh, 11525, Saudi Arabia
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Riyadh, 12311, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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Bratislava, 833 01, Slovakia
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Johannesburg, 2193, South Africa
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Johannesburg, 2196, South Africa
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Pretoria, 0002, South Africa
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Pretoria, 0084, South Africa
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Busan, 602-739, South Korea
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Cheonan-si, 31151, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Badalona, 08916, Spain
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Barcelona, 08025, Spain
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Barcelona, 8035, Spain
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Hospitalet deLlobregat, 08907, Spain
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Jaén, 23007, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Stockholm, 118 83, Sweden
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Hsinchu, 300, Taiwan
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Hualien City, 97002, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 83301, Taiwan
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Tainan, 710, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 104, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Mueang, 50200, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Mersin, 33070, Turkey (Türkiye)
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Edinburgh, EH4 2XU, United Kingdom
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London, E1 1BB, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Surrey, GU2 7XX, United Kingdom
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York, YO31 8HE, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Schmid, MD,PhD,FRCP
Centre for Experimental Cancer Medicine (CECM), Barts Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
June 25, 2019
Study Start
June 25, 2019
Primary Completion
March 16, 2026
Study Completion
March 16, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.