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

Study Evaluates Capivasertib + Fulvestrant for Advanced Breast Cancer

NCT: NCT06764186 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: AstraZeneca · Started: 2025-01-07 · Est. Completion: 2027-12-31

Plain English Summary

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 is a Phase 3 clinical trial sponsored by AstraZeneca studying Locally Advanced or Metastatic Breast Cancer. Tests capivasertib + fulvestrant for patients with HR+/HER2- advanced breast cancer who have relapsed or progressed on endocrine therapy and CDK4/6 inhibitors. For patients with locally advanced or metastatic breast cancer who have tried other treatments. Participation involves taking capivasertib and fulvestrant as prescribed, with regular check-ups. Alternative treatments include other targeted therapies or chemotherapy. The trial aims to enroll 101 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if you have HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations, have relapsed or progressed on endocrine therapy and CDK4/6 inhibitors. Not eligible if you have had more than 2 lines of endocrine therapy or 1 line of chemotherapy for advanced breast cancer. Age: 18+ years. Health: Good overall health, no other major diseases. This trial is studying Locally Advanced or Metastatic Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how long patients can go without needing further treatment, which is crucial for patients with advanced breast cancer. The specific primary outcome measures are: Time to next treatment (TTNT) (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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial fills a gap by testing a new combination for patients who have exhausted other treatment options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Locally Advanced or Metastatic Breast Cancer, where improved treatment options are needed.

Investor Insight

Market size is large, with strong competition but potential for approval given the unmet need in this patient population. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have PIK3CA/AKT1/PTEN alterations and if you have tried other treatments. Participation involves taking two medications daily and attending regular check-ups. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: NA
  • Model: SINGLE_GROUP
  • Masking: NONE
  • Enrollment: 101 participants

Interventions

  • DRUG: 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.
  • DRUG: 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

Primary Outcomes

  • Time to next treatment (TTNT) (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

  • 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).)

Full Eligibility Criteria

Key Inclusion Criteria

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.

Key Exclusion Criteria

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.

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

  • Research Site, Alicante, Spain
  • Research Site, Barcelona, Spain
  • Research Site, Barcelona, Spain
  • Research Site, Barcelona, Spain
  • Research Site, Bilbao (Vizcaya), Spain
  • Research Site, Córdoba, Spain
  • Research Site, Donostia / San Sebastian, Spain
  • Research Site, El Palmar, Spain
  • Research Site, Girona, Spain
  • Research Site, Madrid, Spain
  • ...and 7 more locations

Frequently Asked Questions

What is clinical trial NCT06764186?

NCT06764186 is a Phase 3 INTERVENTIONAL study titled "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." It is currently active, not recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 101 participants.

What conditions does NCT06764186 study?

This trial investigates treatments for Locally Advanced or Metastatic Breast Cancer. The primary condition under study is Locally Advanced or Metastatic Breast Cancer.

What treatments are being tested in NCT06764186?

The interventions being studied include: Fulvestrant (DRUG), Capivasertib (DRUG). 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.

What does Phase 3 mean for NCT06764186?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06764186?

This trial is currently "Active, Not Recruiting." It started on 2025-01-07. The estimated completion date is 2027-12-31.

Who is sponsoring NCT06764186?

NCT06764186 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06764186?

The trial aims to enroll 101 participants. The trial status is active, not recruiting.

How is NCT06764186 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06764186?

The primary outcome measures are: Time to next treatment (TTNT) (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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06764186 being conducted?

This trial is being conducted at 17 sites, including Alicante; Barcelona; Bilbao (Vizcaya); Córdoba and 13 more sites (Spain).

Where can I find official information about NCT06764186?

The official record for NCT06764186 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06764186. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06764186 testing in simple terms?

Tests capivasertib + fulvestrant for patients with HR+/HER2- advanced breast cancer who have relapsed or progressed on endocrine therapy and CDK4/6 inhibitors. For patients with locally advanced or metastatic breast cancer who have tried other treatments.

Why is this trial significant?

This trial fills a gap by testing a new combination for patients who have exhausted other treatment options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06764186?

Key risks include potential side effects from the medications, such as nausea, fatigue, and changes in blood tests. Monitor closely for any new symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06764186?

Ask your doctor if you have PIK3CA/AKT1/PTEN alterations and if you have tried other treatments. Participation involves taking two medications daily and attending regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06764186 signal from an investment perspective?

Market size is large, with strong competition but potential for approval given the unmet need in this patient population. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves taking capivasertib and fulvestrant as prescribed, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.