NCT01823835 - A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer | Biotech Hunter

Enrollment

152

Participants

Timeline

Start Date

December 29, 2014

Primary Completion Date

March 13, 2020

Study Completion Date

March 13, 2020

Conditions

Breast Cancer

Interventions

DRUG

GDC-0810

GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

DRUG

LHRH Agonist

LHRH agonist administered once monthly until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years). Choice of LHRH agonist will be an institutional choice approved for use in breast cancer.

DRUG

Palbociclib

Palbociclib administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Trial Locations (14)

10029

Mount SInai Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

28050

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid

37232

Vanderbilt University Medical Center, Nashville

46010

Hospital Clinico Universitario de Valencia, Valencia

63128

Washington University, St Louis

98109

Seattle Cancer Care Alliance, Seattle

92103-8465

Ucsd Medical Center, San Diego

02114

Massachusetts General Hospital., Boston

02215

Dana Farber Cancer Institute, Boston

1081 HV

VU MEDISCH CENTRUM; Dept. of Medical Oncology, Amsterdam

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona