Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 5, 2020

Primary Completion Date

January 18, 2022

Study Completion Date

May 2, 2023

Conditions
Ovarian Cancer
Interventions
DRUG

Palbociclib 125mg

The Palbociclib capsules supplied for this study contains 75 mg, 100 mg or 125 mg of Palbociclib. It must be taken orally 125 mg once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.

DRUG

Letrozole 2.5mg

Letrozole will be supplied as a 2.5 mg film-coated tablet. It must be taken at the recommended dose of 2.5 mg once daily.

Trial Locations (5)

30.130-100

UFMG - Universidade Federal de Minas Gerais, Belo Horizonte

90.610-000

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre

20.230-130

INCA - Instituto Nacional de Câncer, Rio de Janeiro

01.246-000

ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo

01.323-030

BP - A Beneficência Portuguesa de São Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER

NCT03936270 - Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer | Biotech Hunter | Biotech Hunter