Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
CAPItello-291
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor
3 other identifiers
interventional
818
19 countries
215
Brief Summary
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
Longer than P75 for phase_3
215 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
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2023
CompletedResults Posted
Study results publicly available
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2026
ExpectedApril 30, 2026
April 1, 2026
3.1 years
February 20, 2020
August 15, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Progression Free Survival: Overall Population (Months) in the Global Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Overall Population (Percentage) in the Global Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s). Participants who discontinue treatment prior to progression should continue to be scanned until progression. Kaplan-Meier estimate was used.
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Altered Population (Months) in the Global Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Altered Population (Percentage) in the Global Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause. Kaplan-Meier estimate was used.
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Overall Population (Months) in the China Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s). Participants who discontinue treatment prior to progression should continue to be scanned until progression.
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Overall Population (Percentage) in the China Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s). Participants who discontinue treatment prior to progression should continue to be scanned until progression. Kaplan-Meier estimate was used.
Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Altered Population (Months) in the China Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Altered Population (Percentage) in the China Cohort
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause Kaplan-Meier estimate was used.
Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Study Arms (2)
Capivasertib + fulvestrant
EXPERIMENTALFulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Placebo + fulvestrant
PLACEBO COMPARATORFulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Placebo: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Interventions
Patients will be administered 500 mg (2 injections) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
400 mg BD (2 tablets of 200 mg taken twice a day = total daily dose 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle
Placebo to match 400 mg BD (2 tablets of placebo to match 200 mg taken twice daily = placebo to match total daily dose of 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle
Eligibility Criteria
You may qualify if:
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study
- Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
- Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
- ECOG/WHO PS: 0-1
- Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen (single agent or in combination) and have:
- Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR
- Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy)
- Patients must have measurable disease according to RECIST 1.1 and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
- FFPE tumour sample from primary/recurrent cancer for central testing
You may not qualify if:
- Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement
- More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease
- More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for advanced breast cancer
- Prior treatment with any of the following:
- AKT, PI3K and mTOR inhibitors
- Fulvestrant, and other SERDs
- Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation.
- 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 study treatment initiation.
- Radiotherapy with a wide field of radiation up to 4 weeks before study treatment initiation (capivasertib/placebo) and/or radiotherapy with a limited field of radiation for palliation up to 2 weeks before study treatment initiation (capivasertib/placebo)
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids up to 4 weeks before study treatment initiation
- Any of the following cardiac criteria:
- Mean resting QT interval corrected by Fridericia's formula (QTcF) \>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 corrected QT interval (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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (215)
Research Site
Gilbert, Arizona, 85234, United States
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Orange, California, 92868, United States
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San Francisco, California, 94143, United States
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Whittier, California, 90603, United States
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Fort Myers, Florida, 33905, United States
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Jacksonville, Florida, 32224, United States
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Westwood, Kansas, 66205, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02111-1520, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63156, United States
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Paramus, New Jersey, 07652, United States
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Farmington, New Mexico, 87401, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10011, United States
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Greensboro, North Carolina, 27403, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37211, United States
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Dallas, Texas, 75246, United States
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Midlothian, Virginia, 23114, United States
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Puyallup, Washington, 98373, United States
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Berazategui, B1884BBF, Argentina
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Buenos Aires, C1125ABD, Argentina
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La Rioja, 5300, Argentina
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Rosario, S2000KZE, Argentina
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Viedma, R8500ACE, Argentina
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Adelaide, 5000, Australia
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Ballarat, 3350, Australia
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Birtinya, 4575, Australia
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Box Hill, 3128, Australia
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Concord, 2139, Australia
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Kurralta Park, 5037, Australia
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North Sydney, 2060, Australia
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Orange, 2800, Australia
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Ringwood East, 3135, Australia
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South Brisbane, 4101, Australia
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Waratah, 2298, Australia
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Wendouree, 3355, Australia
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Namur, 5000, Belgium
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Wilrijk, 2610, Belgium
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Winnipeg, Manitoba, R3E 0V9, Canada
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Kingston, Ontario, K7L 2V7, Canada
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North York, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Baoding, 071000, China
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Beijing, 100044, China
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Beijing, 100191, China
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Changchun, 130021, China
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Chongqing, 400030, China
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Chongqing, 400042, China
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Dalian, 116011, China
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Foshan, 528000, China
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Gongshu District, 310022, China
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Guangzhou, 510080, China
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Guangzhou, 510095, China
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Hangzhou, 310003, China
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Hangzhou, 310020, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230022, China
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Jinan, 250001, China
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Linyi, 276001, China
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Nanchang, 330009, China
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Nantong, 226001, China
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Neijiang, 641000, China
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Shanghai, 200032, China
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Shanghai, 200127, China
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Shantou, 515031, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Zhengzhou, 450008, China
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Besançon, 25000, France
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Brest, 29609, France
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Metz, 57085, France
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Pierre-Bénite, 69310, France
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Plerin SUR MER, 22190, France
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Pringy, 74374, France
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Rouen, 76038, France
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Strasbourg, 67065, France
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Toulouse, 31059, France
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Essen, 45130, Germany
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Frankfurt, 60389, Germany
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Gelsenkirchen, 45879, Germany
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Hamburg, 20246, Germany
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Hamburg, 20249, Germany
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Hamburg, 20357, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Mannheim, 68167, Germany
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Minden, 32429, Germany
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München, 80637, Germany
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München, 81377, Germany
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Münster, 48149, Germany
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Paderborn, 33161, Germany
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Potsdam, 14467, Germany
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Budapest, 1122, Hungary
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Budapest, 1134, Hungary
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Debrecen, 4032, Hungary
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Kecskemét, 6000, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5000, Hungary
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Afula, 1834111, Israel
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Bergamo, 24127, Italy
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Candiolo, 10060, Italy
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Catanzaro, 88100, Italy
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Livorno, 57124, Italy
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Macerata, 62100, Italy
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Meldola, 47014, Italy
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Milan, 20141, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Prato, 59100, Italy
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Roma, 00128, Italy
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Chiba, 260-8717, Japan
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Fukuoka, 811-1395, Japan
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Fukushima, 960-1295, 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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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 467-8602, 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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Sapporo, 060-8638, Japan
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Shinagawa-ku, 142-8666, Japan
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Tsu, 514-8507, Japan
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Yokohama, 241-8515, Japan
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Arequipa, AREQUIPA01, Peru
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Lima, LIMA 41, Peru
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Bydgoszcz, 85-796, Poland
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Krakow, 31-501, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-781, Poland
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Samara, 443031, Russia
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Sochi, 354000, Russia
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Busan, 49241, South Korea
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Daegu, 41931, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 22332, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 135-710, South Korea
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Seoul, 8308, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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A Coruña, 15009, Spain
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Barcelona, 08035, Spain
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Barcelona, 8003, Spain
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Córdoba, 14004, Spain
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Hosp de Llobregat(Barcelona), 08907, Spain
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Jaén, 23007, Spain
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La Laguna (Tenerife), 38320, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28033, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Reus, 43204, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 82445, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11259, Taiwan
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Taoyuan, 333, Taiwan
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Aberdeen, AB25 2ZN, United Kingdom
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Bournemouth, BH7 7DW, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4GJ, United Kingdom
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Sutton, SM25PT, United Kingdom
Related Publications (4)
Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. doi: 10.1056/NEJMoa2214131.
PMID: 37256976BACKGROUNDTurner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Murillo SM, Park YH, Sohn JH, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin E, Grinsted L, Schiavon G, Foxley A, Rugo HS. A plain language summary of the CAPItello-291 study: Capivasertib in hormone receptor-positive advanced breast cancer. Future Oncol. 2024;20(37):2901-2913. doi: 10.1080/14796694.2024.2390791. Epub 2024 Sep 16.
PMID: 39283299DERIVEDOliveira M, Rugo HS, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Toi M, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Nowecki Z, Park YH, Sohn JH, Tokunaga E, Yousef S, Zhukova L, Fulford M, Andrews H, Wadsworth I, D'Cruz C, Turner NC; CAPItello-291 study group. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2024 Sep;25(9):1231-1244. doi: 10.1016/S1470-2045(24)00373-5.
PMID: 39214106DERIVEDDilawari A, Buturla J, Osgood C, Gao X, Chen W, Ricks TK, Schaefer T, Avasarala S, Reyes Turcu F, Pathak A, Kalavar S, Bhatnagar V, Collazo J, Rahman NA, Mixter B, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations. J Clin Oncol. 2024 Dec;42(34):4103-4113. doi: 10.1200/JCO.24.00427. Epub 2024 Aug 19.
PMID: 39159418DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were 24 participants who were included in both the global cohort and China cohort which gives a total of 818 participants instead of a total of 842 participants.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
February 20, 2020
First Posted
March 12, 2020
Study Start
April 16, 2020
Primary Completion
May 9, 2023
Study Completion (Estimated)
June 22, 2026
Last Updated
April 30, 2026
Results First Posted
October 27, 2025
Record last verified: 2026-04
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 refer 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.