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Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

NCT07281833 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-27

No results posted yet for this study

Summary

This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment.

The goal of this study is

1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time "on treatment" with capivasertib.
2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.

There is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..

Participants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.

Conditions

Interventions

DRUG

Capivasertib

2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Peter Schmid, PHD Dr · Westdeutsche Studiengruppe GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2030-03-31
Completion
2030-03-31

Countries

  • Belgium
  • Germany
  • Portugal

Study Locations

More Related Trials

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 NCT07281833 on ClinicalTrials.gov