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Effect of Capivasertib on ctDNA in ER Positive Breast Cancer

NCT06613516 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-24

No results posted yet for this study

Summary

There is growing evidence that cancer DNA (called circulating tumour DNA - ctDNA) in the blood is often an early sign that the cancer is likely to return. The aim of this study is to investigate whether treating women who have detectable ctDNA in their blood with a drug called Capivasertib can help control ctDNA levels and prevent developing metastatic or secondary breast cancer.

A recruitment of 20 women with oestrogen receptor (ER) positive breast cancer (who are already on standard of care hormone therapy who are being treated with curative intent) is aimed for; which means that the disease has not yet spread to distant parts of the body. Each subject will be dosed with 400mg of Capivasertib twice a day for a maximum period of two years.

Conditions

Interventions

DRUG

Capivasertib

Capivasertib is a selective inhibitor of the kinase activity of the serine/threonine Akt/PKB pathway that may potentially provide clinical benefit over a range of therapeutic indications. Capivasertib comes in capsule form in two forms; 160mg or 200mg

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sharp

    collaborator INDUSTRY

  • Natera, Inc.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Dr Farah Rehman · Imperial College Healthcare Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-09-16
Completion
2025-09-16

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613516 on ClinicalTrials.gov