Locally Advanced or Metastatic Breast CancerPhase 3CAPItanaNCT06764186
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
A Phase 3 study testing Fulvestrant and Capivasertib in people with Locally Advanced or Metastatic Breast Cancer, run by AstraZeneca at 17 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- Fulvestrant and Capivasertib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 17 sitesSpain
- Study dates
- 7 Jan 2025to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- Prior/concomitant therapy:
- More than 2 lines of endocrine therapy or in combination with CDK4/6i 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 ABC.
- AKT1, PIK3CA and mTOR inhibitors not allowed.
- Adequate washout or dose reduction may be required for some CYP3A.
- Participation in another clinical study with a study intervention.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Research Site
Alicante, 03010
Research Site
Barcelona, 08003
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Bilbao (Vizcaya), 48013
Research Site
Córdoba, 14004
Research Site
Donostia / San Sebastian, 20014
Research Site
El Palmar, 30120
Research Site
Girona, 17007
Research Site
Madrid, 28041
Research Site
Oviedo, 33011
Research Site
Palma deMallorca, 07010
Research Site
Salamanca, 37007
Research Site
Santander, 39008
Research Site
Seville, 41073
Research Site
Valencia, 46026
Research Site
Zaragoza, 50009
About this study
Official title: A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
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.
Read the detailed description
Phase IIIb, multicentre, single arm, Spain study assessing effectiveness/safety of capivasertib+fulvestrant in locally advanced (inoperable) or metastatic HR+/HER2- BC with the PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor. Capivasertib will be administered as 400mg BD, 4 days on 3 days off in combination with fulvestrant at the approved dose of monthly 500mg (2 × 5mL IV), with an additional loading dose in Cycle 1.
- Being tested
- Fulvestrant, Capivasertib
- Keywords
- Luminal, PIK3CA/AKT1/PTEN, PI3K/AKT pathway, capivasertib, HR+ / HER2-, fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
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.
CapivasertibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Capivasertib + fulvestrant | Experimental | Fulvestrant: 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. Receives: Drug: Fulvestrant; Drug: Capivasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Safety and tolerability will be evaluated in terms of AEs, SAEs, and AESIs.
Measured: From enrollment up to at least 30 days (+7 days) after last dose of capivasertib + fulvestrant treatment
Time to first Subsequent Chemotherapy (TFSC)
TFSC is defined as the time from the date of first dose of capivasertib + fulvestrant treatment until the first date of the first cycle of the subsequent chemotherapy, or death from any cause.
Measured: 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)
PFS is defined as time from the first dose of capivasertib + fulvestrant treatment to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined progressive disease as assess by the investigator or death due to any cause.
Measured: 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)
Objective Response Rate (ORR) using site investigator assessments according to RECIST 1.1.
Measured: From start of capivasertib+fulvestrant treatment to progression/death or up to 6 months after Last Subject Inclusion
Overall survival (OS)
OS is defined as the time from first dose of capivasertib + fulvestrant treatment until the date of death due to any cause.
Measured: From date of first dose of capivasertib + fulvestrant treatment until death, withdrawal of consent, or the end of the study (approximately 24 months).
Number of patients with change in EORTC QLQ C30 and QLQ-BR42, respectively
Change from baseline in score on EORTC QLQ-C30 and EORTC QLQ-BR42 reported at enrollment and then throughout the prospective study follow-up to end of the capivasertib + fulvestrant
Measured: From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion
Time to deterioration
Time to deterioration defined as the time from the date of the first dose of treatment until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit at least 14 days apart or death.
Measured: From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion
Number of patients with change from in PGI-S
Change from baseline in score on the PGI-S to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days at study enrollment and then weekly throughout the prospective study follow-up on study treatment
Measured: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in PGI-II
Change from baseline in score on the PGI-TT to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days at study enrollment and then weekly throughout the prospective study follow-up on study treatment
Measured: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in Daily bowel habits
Change from baseline in score on the Daily bowel habits diary (BSFS) to classify the stools based on their appearance at study enrollment and then daily oughout the prospective study follow-up on study treatment
Measured: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in ADAQ
Change from baseline in score on ADAQ to assess the adherence of capivasertib + fulvestrant treatment at study enrollment and then weekly throughout the prospective study follow-up on study treatment
Measured: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start7 Jan 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L., SOLTI Breast Cancer Research Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764186
- Sponsor's protocol ID
- D3612L00005
- Acronym
- CAPItana
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
- ClinicalTrials.gov ID
- NCT06764186
- Acronym / sponsor ID
- CAPItana / D3612L00005
- Keywords
- Luminal, PIK3CA/AKT1/PTEN, PI3K/AKT pathway, capivasertib, HR+ / HER2-, fulvestrant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L., SOLTI Breast Cancer Research Group
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase IIIb, multicentre, single arm, Spain study assessing effectiveness/safety of capivasertib+fulvestrant in locally advanced (inoperable) or metastatic HR+/HER2- BC with the PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor. Capivasertib will be administered as 400mg BD, 4 days on 3 days off in combination with fulvestrant at the approved dose of monthly 500mg (2 × 5mL IV), with an additional loading dose in Cycle 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capivasertib + fulvestrant | Experimental | Drug: Fulvestrant, Drug: CapivasertibFulvestrant: 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fulvestrant2 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. | Drug | Capivasertib + fulvestrant |
| Capivasertib400 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 | Drug | Capivasertib + fulvestrant |
Primary outcome
Time to next treatment (TTNT)
Time frame: 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
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).
11 secondary outcomes
Number of patients with AEs.
Time frame: From enrollment up to at least 30 days (+7 days) after last dose of capivasertib + fulvestrant treatment
Time to first Subsequent Chemotherapy (TFSC)
Time frame: 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)
Time frame: 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)
Time frame: From start of capivasertib+fulvestrant treatment to progression/death or up to 6 months after Last Subject Inclusion
Overall survival (OS)
Time frame: From date of first dose of capivasertib + fulvestrant treatment until death, withdrawal of consent, or the end of the study (approximately 24 months).
Number of patients with change in EORTC QLQ C30 and QLQ-BR42, respectively
Time frame: From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion
Time to deterioration
Time frame: From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion
Number of patients with change from in PGI-S
Time frame: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in PGI-II
Time frame: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in Daily bowel habits
Time frame: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Number of patients with change in ADAQ
Time frame: From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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 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.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fulvestrant and Capivasertib in people with Locally Advanced or Metastatic Breast Cancer, run by AstraZeneca at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to next treatment (TTNT) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.