Capivasertib + Palbociclib + Fulvestrant for HR+/HER2- Advanced Breast Cancer (CAPItello-292).

Official Title

A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

Summary:

A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292).

Trial Description

Primary Outcome:

  • Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.
  • Phase Ib: 2. The number of participants with treatment-related adverse events.
  • Phase Ib: 3. The number of participants with treatment-related serious adverse events.
  • Phase III: 1. Progression Free Survival (PFS).
Secondary Outcome:
  • Phase Ib: 1. PK parameters for palbociclib: Cmax.
  • Phase Ib: 2. PK parameters for palbociclib: AUC0-72h.
  • Phase Ib: 3. PK parameters for palbociclib: AUC0-24h.
  • Phase Ib: 4. PK parameters for palbociclib: Cmin.
  • Phase Ib: 5. PK parameters for capivasertib: Cmax.
  • Phase Ib: 6. PK parameters for capivasertib: AUC0-12h.
  • Phase Ib: 7. PK parameters for capivasertib: Cmin.
  • Phase Ib: 8. Objective Response Rate (ORR).
  • Phase Ib: 9. Clinical Benefit Rate (CBR) at 24 weeks.
  • Phase Ib: 10. Duration of Response (DoR).
  • Phase Ib: 11. Progression Free Survival (PFS).
  • Phase III: 1. Overall Survival (OS).
  • Phase III: 2. Progression Free Survival (PFS) in PIK3CA/ AKT1/ PTEN-altered population.
  • Phase III: 3. Progression Free Survival 2 (PFS2).
  • Phase III: 4. Objective Response Rate (ORR).
  • Phase III: 5. Duration of Response (DoR).
  • Phase III: 6. Clinical Benefit Rate (CBR) at 24 weeks.
  • Phase III: 7. EORTC QLQ-30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items).
  • Phase III: 8. 1.EORTC QLQ BR45 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module).
  • Phase III: 9. Time to definitive deterioration of the ECOG (Eastern Cooperative Oncology Group) performance status.
  • Phase III: 10. Plasma concentration of capivasertib pre- and post-dose.
  • Phase III: 11. The number of participants with adverse events.
  • Phase III: 12. The number of participants with serious adverse events.
This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with palbociclib and fulvestrant in participants with endocrine-resistant locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of palbociclib + fulvestrant are established, the dose and schedule for the triplet combination (capivasertib + palbociclib + fulvestrant) needs to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will confirm the recommended Phase III doses (RP3D) and schedule of administration of capivasertib and palbociclib for the triplet combination including fulvestrant which will then be used in the Phase III part of this study.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society