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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat (kobiety i mężczyźni)
- •Kobiety przed menopauzą lub w okresie przejściowym muszą zgodzić się na leczenie lekiem GNRH
- •Kobiety po menopauzie: wiek 60+ lat LUB bezmiesiączki przez co najmniej 12 miesięcy LUB po usunięciu obu jajników
- •Potwierdzona histologicznie raka piersi o typie HR+/HER2- (dodatnia receptory hormonalne, ujemna HER2)
- •Raka zaawansowany lub nieoperacyjny, z dowodem na progresję choroby
- •Poprzednie leczenie hormonalne z potwierdzonym nawrotem lub progresją choroby
- •Podpisana świadoma zgoda pacjenta na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (16)
Institut Jules Bordet
Anderlecht, Belgium
St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie
Cologne, Germany
Universitätsklinikum Essen
Essen, Germany
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach, Germany
Universitätsklinikum Münster AöR Brustzentrum
Münster, 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
Trial contact
Rico Laage, Dr.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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