Pre-operative GDC-9545 for women with stage 1-3 operable breast cancer
Research type
Research Study
Full title
A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women with Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
IRAS ID
259731
Contact name
Peter Schmid
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2018-003798-85
Clinicaltrials.gov Identifier
IND Number, 132673
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Breast cancer is the most frequent cancer diagnosed in women and accounts for approximately 15% of all cancer deaths. Roughly 80% of breast cancers express the oestrogen receptor (ER) and most of these cancers depend on ER for tumour growth and progression. Controlling the production and activity of oestrogen is the main approach in women with ER-positive breast cancer. Despite the effectiveness of current hormone therapies, many patients relapse and become resistant to these agents.
GDC-9545 is being developed for ER-positive breast cancer. It is designed to block oestrogen and has shown efficacy in non-clinical studies. It is also being tested in patients with metastatic ER-positive breast cancer in an ongoing study. To date, GDC-9545 has been tolerable with early signs of anti-tumour activity at all doses.
The purpose of this study is to test the safety of GDC-9545 and the effects on certain tumour protein markers associated with breast cancer after GDC-9545 has been taken for about 14 days.
Post-menopausal women with ER-positive (HER-negative) untreated breast cancer that has not metastasised and surgery is planned to remove the breast cancer tissue more than 14 days from consenting may be eligible.
After screening, eligible patients will be assigned to one of three treatment groups; each group will be given a different dose of GDC-9545. GDC-9545 tablets are taken orally every day for about 14 days. Patients will visit the clinic on Days 1, 8, 15 (for surgery to remove the breast cancer tissue) and 43. Study procedures include physical examinations, vital signs, blood and urine samples, ECGs, ultrasound and tissue biopsies. Total time in the study will be 2-3 months.
This study is sponsored by Genentech, Inc. Approximately 45 patients will participate in this study in Europe and the USA with xxx patients from 2 hospitals in the UK.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0341
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion