Ascent-07
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
IRAS ID
1007663
Contact name
Pelin Cinar
Contact email
Sponsor organisation
Gilead Sciences Inc.
Research summary
This is a phase 3 (this means that it has already been tested on a smaller group of patients before) multicentre study being conducted by Gilead Sciences, Inc. This study will test an experimental drug named Sacituzumab Govitecan (SG) for the treatment of Hormone Receptor Positive (HR+) /Human Epidermal Growth Factor 2 negative (HER2-) locally advanced unresectable or metastatic breast cancer in patients who have received prior endocrine therapy. This means cancer which cannot be removed through surgery or has spread from the breast to other parts of the body. The study aims to see if SG can improve survival of participants with HR+/HER2- metastatic breast cancer and their tumour does not grow or spread when compared to current available standard treatments. Information on the side effects, treatment benefit, quality of life, and other supporting data will also be collected in this study.
SG is a drug that will be infused intravenously (into or within a vein). The duration the participant receives the drug will depend on the number of cycles of treatment they receive. SG is given on days 1 and 8 of a 21 day cycle.
During the study, participants will have the following procedures (but not limited to): physical examinations, vital signs (such as heart rate), blood & urine sampling, pregnancy testing, radiological assessments, and questionnaires. Participants will continue receiving study drug until they withdraw their consent, no longer tolerate the study drug, or their disease worsens. Participants will be contact for follow ups after treatment ends. This will occur every 12 weeks or more frequently (if needed) for the duration of follow up period.
Approximately 650 patients will take part in this world-wide study, 13 in the UK (all at National Health Service sites). All participants must be over 18 years old. The study is not blinded and there is no placebo (dummy drug), both participant and doctor will know what treatment they are on.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0448
Date of REC Opinion
14 Sep 2023
REC opinion
Further Information Favourable Opinion