A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
CAPItana
1 other identifier
interventional
101
1 country
17
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2025
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2024
CompletedStudy Start
First participant enrolled
January 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 8, 2026
April 1, 2026
3 years
November 28, 2024
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to next treatment (TTNT)
Time to next treatment (TTNT1 is defined as the time from the date of first dose of capivasertib+fulvestrant until the first subsequent anti-cancer therapy after discontinuation of study treatment or death due to any cause).
From start of date of first dose of capivasertib+fulvestrant treatment to date of the first subsequent anti-cancer therapy or death or up to within approximately 12 months after Last Subject Inclusion
Secondary Outcomes (11)
Number of patients with AEs.
From enrollment up to at least 30 days (+7 days) after last dose of capivasertib + fulvestrant treatment
Time to first Subsequent Chemotherapy (TFSC)
From start of capivasertib+fulvestrant treatment to the first Subsequent Chemotherapy, death, withdrawal of consent or the end of study (approximately 24 months)
Progression-free survival (PFS)
From date of first dose of Capivasertib + fulvestrant until date of disease progression, death, withdrawal of consent or the end of study (approximately 24 months)
Objective Response Rate (ORR)
From start of capivasertib+fulvestrant treatment to progression/death or up to 6 months after Last Subject Inclusion
Overall survival (OS)
From date of first dose of capivasertib + fulvestrant treatment until death, withdrawal of consent, or the end of the study (approximately 24 months).
- +6 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Histologically confirmed HR+/HER2- breast cancer (primary or metastatic):
- HR+ defined as ER+ with or without PRg+
- HER2- defined as IHC 0 or 1+, or IHC 2+/ISH-
- Patient with tumours harbouring at least one PIK3CA/AKT1/PTEN qualifying alteration detected by a validated test (including NGS on tissue, cell block, or if tissue/cell block is not available, on ctDNA, as per protocol requirements. If alteration is initially detected by a method other than NGS, NGS on tissue/cell block must be performed within 45 days unless not available, which must be documented.)
- Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression.
- Patients must have received treatment with an ET in combination with CDK4/6i 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 ET with CDK4/6i, OR
- Radiological evidence of progression while on prior ET with CDK4/6i administered as a treatment line for locally advanced or metastatic breast cancer.
- Informed consent
- Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status ≤ 2 at enrollment (not more than 20% of patients with ECOG PS2 will be allowed).
- Reproduction:
- Women of childbearing potential (WOCBP) patients with ovarian suppression induced by LHRH agonist should agree to use 2 forms of highly effective methods of accepted contraception to prevent pregnancy.
- Male patients should use barrier contraception.
You may not qualify if:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence.
- Disease burden making the patient ineligible for endocrine therapy per the investigator judgement.
- Unresolved toxicities from prior therapy greater than CTCAE grade 1.
- Leptomeningeal metastases or symptomatic, unstable, or steroid-dependent brain metastases.
- HbA1c ≥8.0% (63.9 mmol/mol).
- Inadequate bone marrow reserve or organ function.
- Severe or uncontrolled systemic diseases, uncontrolled hypertension, active infections including hepatitis B, hepatitis C, HIV, and confirmed COVID-19.
- Known abnormalities in coagulation.
- Refractory nausea, vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow formulated product, or significant bowel resection.
- Previous allogenic bone marrow or solid organ transplant.
- Known immunodeficiency syndrome.
- Unknown or non-altered PIK3CA/AKT1/PTEN-status.
- Evidence of dementia altered mental status or any psychiatric condition.
- Pregnant women.
- Participants with significant QT interval prolongation or a history of related cardiac conditions, including arrhythmias or recent cardiac procedures.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Apices Soluciones S.L.collaborator
- SOLTI Breast Cancer Research Groupcollaborator
Study Sites (17)
Research Site
Alicante, 03010, Spain
Research Site
Barcelona, 08003, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Bilbao (Vizcaya), 48013, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Donostia / San Sebastian, 20014, Spain
Research Site
El Palmar, 30120, Spain
Research Site
Girona, 17007, Spain
Research Site
Madrid, 28041, Spain
Research Site
Oviedo, 33011, Spain
Research Site
Palma deMallorca, 07010, Spain
Research Site
Salamanca, 37007, Spain
Research Site
Santander, 39008, Spain
Research Site
Seville, 41073, Spain
Research Site
Valencia, 46026, Spain
Research Site
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2024
First Posted
January 8, 2025
Study Start
January 7, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 8, 2026
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 PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.