A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 7, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Locally Advanced or Metastatic Breast Cancer
Interventions
DRUG

Fulvestrant

2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter.

DRUG

Capivasertib

400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle

Trial Locations (18)

10003

NOT_YET_RECRUITING

Research Site, Cáceres

14004

RECRUITING

Research Site, Córdoba

17007

RECRUITING

Research Site, Girona

20014

RECRUITING

Research Site, Donostia / San Sebastian

28041

RECRUITING

Research Site, Madrid

30120

RECRUITING

Research Site, El Palmar

33011

RECRUITING

Research Site, Oviedo

37007

RECRUITING

Research Site, Salamanca

39008

RECRUITING

Research Site, Santander

41073

RECRUITING

Research Site, Seville

46026

RECRUITING

Research Site, Valencia

48013

RECRUITING

Research Site, Bilbao (Vizcaya)

50009

RECRUITING

Research Site, Zaragoza

03010

RECRUITING

Research Site, Alicante

08003

RECRUITING

Research Site, Barcelona

08035

RECRUITING

Research Site, Barcelona

08036

RECRUITING

Research Site, Barcelona

07010

RECRUITING

Research Site, Palma deMallorca

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Apices Soluciones S.L.

INDUSTRY

collaborator

SOLTI Breast Cancer Research Group

OTHER

lead

AstraZeneca

INDUSTRY