Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04305496

Acronym / sponsor ID

CAPItello-291 / D3615C00001

Conditions

Locally Advanced (Inoperable) or Metastatic Breast Cancer

Keywords

Locally advanced (inoperable) or Metastatic Breast Cancer

Phase

Phase 3

Study type

Interventional

Recruitment status

Active, not recruiting

Enrolment

818 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

16 Apr 2020 (actual)

Primary completion

9 May 2023 (actual)

Study completion

22 Jun 2026 (estimated)

First posted

12 Mar 2020 (actual)

Results

Posted 27 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

2

Model description

Double-blind Randomised Study

Who may qualify

Ages

18 to 130 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Progression Free Survival: Overall Population (Months) in the Global Cohort

   Time frame: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

   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).

2. Progression Free Survival: Overall Population (Percentage) in the Global Cohort

   Time frame: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

   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.

3. Progression Free Survival: Altered Population (Months) in the Global Cohort

   Time frame: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

   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.

4. Progression Free Survival: Altered Population (Percentage) in the Global Cohort

   Time frame: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

   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.

5. Progression Free Survival: Overall Population (Months) in the China Cohort

   Time frame: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

   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.

6. Progression Free Survival: Overall Population (Percentage) in the China Cohort

   Time frame: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

   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.

7. Progression Free Survival: Altered Population (Months) in the China Cohort

   Time frame: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

   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.

8. Progression Free Survival: Altered Population (Percentage) in the China Cohort

   Time frame: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 37256976Turner 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.
• Derived from this study: PubMed 39283299Turner 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.
• Derived from this study: PubMed 39214106Oliveira 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.
• Derived from this study: PubMed 39159418Dilawari 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.
• CSP redactedLink provided by the sponsor.
• SAP redactedLink provided by the sponsor.
• CSR SynopsisLink provided by the sponsor.
• CSR Synopsis China CohortLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

215 sites in 19 countries: see every site and its status.