GDC-0810 vs fulvestrant in advanced/metastatic ER+/HER2- Breast Cancer
Research type
Research Study
Full title
A phase II, open-label, randomized study of GDC-0810 versus Fulvestrant in postmenopausal women with advanced or metastatic ER+/HER2 breast cancer resistant to aromatase inhibitor therapy
IRAS ID
182262
Contact name
Peter Schmid
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2015-000106-19
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
This is a multicentre, randomised, open-label trial of GDC-0810 versus fulvestrant. Participants will be postmenopausal women with advanced or metastatic ER+/HER2- breast cancer who are resistant to aromatase inhibitor therapy or who have experienced recurrence or progression of their disease while receiving aromatase inhibitor therapy, or who have relapsed within 6 months after completing aromatase inhibitor therapy.
The research study drug to be investigated is GDC-0810. The study will evaluate the efficacy, pharmacokinetics, safety and tolerability of GDC-0810 compared with fulvestrant.
Approximately 152 patients will be enrolled in this study globally.
Randomisation will be in a 1:1 ratio and will allocate participants into Arm A or Arm B. Participants enrolled into Arm A will receive GDC-0810, to be taken orally, and those enrolled into Arm B will receive fulvestrant, which will be administered intramuscularly.
Participants will receive study treatment in 28-day cycles until disease progression, intolerable toxicity, withdrawal, study completion or study termination.
Participants are expected to be in the study for approximately 2 years and will attend around 8 scheduled clinic visits, including screening, treatment visits and study drug discontinuation, plus further visits for additional treatment cycles. After study discontinuation, participants will be followed up every 3 months until death, loss to follow-up, withdrawal or study termination. Procedures include physical exams, ECGs, transvaginal ultrasounds, blood samples, CT/MRI scans and bone scans.
The Sponsor is Genentech, Inc., a member of Roche Group.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1600
Date of REC Opinion
2 Dec 2015
REC opinion
Further Information Favourable Opinion