Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivas
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 capiv
| Condition(s) | Breast Cancer, HR-positive Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenable to treatment with an GNRH agonist. Patients are to have commenced concomitant treatment with GNRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue it for the duration of the study. b. Post-menopausal women are defined as: i. aged ≥60 years of age, OR ii. aged \<60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These patients should also have serum oestradiol and |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | West German Study Group |
| Locations | Anderlecht, Belgium; Liège, Belgium; Cologne, North Rhine-Westphalia, Germany; Essen, North Rhine-Westphalia, Germany; Mönchengladbach, North Rhine-Westphalia, Germany; Münster, North Rhine-Westphalia, Germany (+1 more sites) |
| Start date | 2025-11-27 |
| NCT ID | NCT07281833 |
| Official listing | https://clinicaltrials.gov/study/NCT07281833 |