RecruitingPhase 3NCT07281833

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

An Interventional, Open-label, 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


Sponsor

Women's Cancer Study Group GmbH

Enrollment

250 participants

Start Date

Nov 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing whether capivasertib, a targeted therapy drug, added to standard hormone-blocking treatment improves outcomes for patients with hormone receptor-positive, HER2-negative advanced breast cancer whose cancer progressed on prior hormone therapy. **You may be eligible if...** - You are 18 or older (male or female) - You have hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer - Your cancer progressed while on a prior endocrine (hormone-blocking) treatment - Pre-menopausal women must be willing to use a GnRH agonist (a hormone-suppressing injection) throughout the study **You may NOT be eligible if...** - You have not previously received endocrine therapy for advanced disease - You have certain genetic mutations, serious organ problems, or other conditions that would make this treatment unsafe - You are pregnant or unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapivasertib

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


Locations(16)

Institut Jules Bordet

Anderlecht, Belgium

St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

Mönchengladbach, North Rhine-Westphalia, Germany

Universitätsklinikum Münster AöR Brustzentrum

Münster, North Rhine-Westphalia, Germany

Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide

Cologne, Germany

Evanglisches Kliniken Essen Mitte

Essen, Germany

AGAPLESION Markus Krankenhaus

Frankfurt, Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Germany

Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz

Hildesheim, Germany

Klinikum der Universität München

München, Germany

Rotkreuzkliniken München

München, Germany

MVZ Media Vita (St. Franziskus-Hospital Münster)

Münster, Germany

MKS St. Paulus GmBH Mariankrankenhaus

Schwerte, Germany

Universitätsklinikum Ulm

Ulm, Germany

Champalimaud Clinical Centre

Lisbon, Portugal

View Full Details on ClinicalTrials.gov

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NCT07281833


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