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

Study identifier:D3612L00005

ClinicalTrials.gov identifier:NCT06764186

EudraCT identifier:N/A

CTIS identifier:2024-513952-13-00

Recruiting

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

Medical condition

Locally Advanced or Metastatic Breast Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Fulvestrant, Capivasertib

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 08 Jan 2025

Estimated Primary Completion Date: 31 Jan 2028

Estimated Study Completion Date: 31 Jan 2028

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Collaborators

APICES Soluciones S.L., SOLTI

Inclusion and exclusion criteria

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 in tissue, using a NGS test acceptable by the conditions included in the SmPC.
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.

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No locations available

Arms	Assigned Interventions
Experimental: Capivasertib + fulvestrant 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.	-

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]