Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 18, 2020

Primary Completion Date

December 14, 2023

Study Completion Date

December 14, 2023

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Combination, Palbociclib + Binimetinib

"Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression.~If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily."

Trial Locations (8)

25198

Hospital Universitari Arnau de Vilanova de Lleida, Lleida

28006

Hospìtal Universitario de la Princesa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28223

Hospital QuirónSalud Madrid, Madrid

28942

Hospital Universitario de Fuenlabrada, Madrid

46010

Hospital Clínico Universitario de Valencia, Valencia

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Apices Soluciones S.L.

INDUSTRY

collaborator

Pierre Fabre Ibérica, S.A.

INDUSTRY

lead

Fundacion Oncosur

NETWORK

NCT04494958 - Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer | Biotech Hunter | Biotech Hunter