Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Conditions

• Locally Advanced (Inoperable) or Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Capivasertib — DRUG
  Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
• Fulvestrant — DRUG
  Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
• Palbociclib — DRUG
  Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.
• Ribociclib — DRUG
  Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.
• Abemaciclib — DRUG
  Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle

Study Details

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Key Dates

First listed

Apr 28, 2021

Start date

May 10, 2021

Status verified

Aug 2026

Primary completion

Nov 1, 2027

Completion

Aug 14, 2029

Study Design

Enrollment

893 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Capivasertib Plus Palbociclib and Fulvestrant
  Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b)
• Experimental: Capivasertib Plus Ribociclib and Fulvestrant
  Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b)
• Experimental: Capivasertib Plus Abemaciclib and Fulvestrant
  Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b)
• Experimental: Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)
  Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)
• Active Comparator: Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)
  Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)

Primary Outcome Measure

Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol. [ Time Frame: Within the first 28 day cycle. ]

Locations (40)