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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT04862663
Phase
PHASE3
Status
Recruiting
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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

Start date
May 10, 2021
Status verified
May 2026
Primary completion
Nov 1, 2027
Completion
Aug 14, 2029

Study Design

Enrollment
895 participants (estimated)
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. ]

Central Contacts

Locations (54)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteFountain ValleyCalifornia92708-
Research SiteGlendaleCalifornia91204-
Research SiteLos AngelesCalifornia90033-
Research SiteLos AngelesCalifornia90048-
Research SiteNapaCalifornia94558-
Research SiteNewport BeachCalifornia92663-
Research SiteSan FranciscoCalifornia94158-
Research SiteSanta BarbaraCalifornia93105-
Research SiteSanta RosaCalifornia92805-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06510-
Research SiteNewarkDelaware19713-
Research SiteQuincyIllinois62305-
Research SiteFort WayneIndiana46804-
Research SiteLouisvilleKentucky40202-
Research SiteLouisvilleKentucky40202-
Research SiteBaton RougeLouisiana70809-
Research SiteCovingtonLouisiana70433-
Research SiteAnnapolisMaryland21401-
Research SiteBaltimoreMaryland21202-
Research SiteBaltimoreMaryland21229-
Research SiteBostonMassachusetts02215-
Research SiteDetroitMichigan48236-
Research SiteGrand RapidsMichigan49503-
Research SiteHannibalMissouri63401-
Research SiteSt LouisMissouri63110-
Research SiteOmahaNebraska68130-
Research SiteCamdenNew Jersey08103-
Research SiteBrooklynNew York11220-
Research SiteMineolaNew York11501-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SiteDurhamNorth Carolina27710-
Research SiteGreshamOregon97030-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15213-
Research SiteYorkPennsylvania17403-
Research SiteProvidenceRhode Island02903-
Research SiteGreenvilleSouth Carolina29607-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75246-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteIrvingTexas75063-
Research SiteSan AntonioTexas78229-
Research SiteSan AntonioTexas78240-
Research SiteSalt Lake CityUtah84106-
Research SiteFairfaxVirginia22031-
Research SiteFalls ChurchVirginia22042-
Research SiteMidlothianVirginia23114-
Research SiteNorfolkVirginia23502-
Research SiteTacomaWashington98405-

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