Phase 2 study of belzutifan for ER+/HER2- metastatic breast cancer
Research type
Research Study
Full title
A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)
IRAS ID
1010135
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
This trial is testing belzutifan (MK-6482) plus fulvestrant in people with breast cancer.
Belzutifan is an experimental drug that has not been approved for the treatment of breast cancer.
This trial will compare belzutifan plus fulvestrant compared to everolimus plus an endocrine therapy (ET); either exemestane or fulvestrant (selected by the trial doctor). Fulvestrant, everolimus and exemestane are standard treatments for breast cancer.
This trial is being done to:
• Test the safety of belzutifan plus fulvestrant compared to everolimus plus an ET
• See how well belzutifan plus fulvestrant works compared to everolimus plus an ET
About 120 participants will take part in the trial from approximately 10 countries. They will have been diagnosed with ER+/HER2- breast cancer that cannot be removed surgically, has come back, or has spread to other areas of their body, and has grown on or after receiving hormone-blocking treatments and are at least 18 years old.Participants will have an equal chance of receiving either:
• Belzutifan plus fulvestrant
• Everolimus plus an ET (fulvestrant or exemestane)The participants, their trial doctor, and the trial staff will know what treatment they are getting.
Belzutifan, exemestane, and everolimus are tablets that are taken by mouth. All are taken once a day.
Fulvestrant is an injection. It is injected into a muscle once every 28 days. One cycle lasts for 28 days. During the first cycle of fulvestrant, participants will get one extra injection on the 15th day of the cycle.
During the trial, participants will give blood and urine samples and possibly a tumour sample from a biopsy. They will also have imaging tests and physical examinations.
Participants could be in the trial for up to 5 years. How long they are in the trial depends on their health and how well they tolerate the trial drugs.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0477
Date of REC Opinion
6 Aug 2024
REC opinion
Further Information Favourable Opinion