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 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-2

Trial Details

NCT ID
NCT07281833
Phase
PHASE3
Sponsor
West German Study Group
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Capivasertib
Locations (sample)
  • Anderlecht, Belgium|50.83619,4.31454
  • Liège, Belgium|50.63373,5.56749
  • Cologne, North Rhine-Westphalia, Germany|50.93333,6.95
  • Essen, North Rhine-Westphalia, Germany|51.45657,7.01228
  • Mönchengladbach, North Rhine-Westphalia, Germany|51.18539,6.44172

Key Eligibility Criteria

  • 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 amena…
  • 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 …
  • Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. T…

For full eligibility, visit ClinicalTrials.gov.

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