NCT07281833

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: West German Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Trial type: Interventional Clinical indication: HR+/HER2- advanced breast cancer under progress IMP: capivasertib (CAPI) AxMP: fulvestrant (FULV) AxMP: GnRH agonists (GnRH) Dose and route of administration: IMP: 2x400 mg, peroral, for 4 days, followed by 3 days off treatment AxMP FULV: 500 mg, intramuscular, every 28 days AxMP GnRH-agonist: according to SmPC of the medicinal product used Treatment arm 1 * capivasertib (CAPI) * with and without eHealth support (CANKADO PRO-active) Type of control: * No active control or comparator for Arm 1-treatment * Historical study data from CAPItello-291 study Trial blinding: Not applicable; open-label Number of trial participants: N=250 patients (Screening of about 600 patients expected to recruit 250 patients with alterations of the PIK3CA/AKT1/PTEN biomarkers) Estimated enrolment period: 24 months Estimated duration of trial: Recruitment interval (expected 24 months) plus minimum 36 months follow-up (after LPI). * Expected FPI: Q4 / 2024 - Q1 / 2025 * EOS: Q1 / 2030 Duration of participation: All patients will be followed-up from time point of inclusion until global End of Study (EOS) or death, whatever happens first. Length of study treatment per patient: Capivasertib (CAPI) will be started after inclusion in the study and be administered until next progression, death, until any unbearable medical or other reason occurs that requires end of study for the patient, or global End of Study (EOS), whatever happens first.

Conditions

• Breast Cancer
• HR-positive Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Capivasertib	2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Timeline

• Start date: 2025-11-27
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2025-12-15
• Last updated: 2026-02-27

Locations

7 sites across 3 countries: Belgium, Germany, Portugal