DB-1303-O-3002_DYNASTY-Breast02
Research type
Research Study
Full title
A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)
IRAS ID
1009062
Contact name
Carsten Kriebitzsch
Contact email
Sponsor organisation
Dualitybio Inc.
Eudract number
2023-507333-17
Clinicaltrials.gov Identifier
Research summary
The DYNASTY-Breast02 study is looking at whether the investigational medication, DB-1303, works to slow or stop cancer growth compared with other standard treatments.
The study will also try to answer several questions about the investigational medication, such as how:
• safe it is
• well the body tolerates it
• it is processed by the body
• it affects patients’ quality of life and their need for medical care
• it affects the body’s immune system.Participants in the study will be breast cancer patients whose disease did not get better with previous treatment or has spread to other parts of the body.
The study will include about 532 participants worldwide across approximately 230 hospitals.
Half of participants will receive the investigational medication and the other half will receive 1 of 3 standard treatments selected by their study doctor. The standard treatments are capecitabine, paclitaxel or nab-paclitaxel and they are all approved chemotherapy for breast cancer. Which study medication participants receive will be decided by chance. This study is open label which means both the study doctor and the participant will know which study medication they are receiving.
How long participants will be in the DYNASTY-Breast02 study depends on how their cancer responds to the study medication or subject to sponsor’s decision on the study. Participants will need to stop taking the study medication if their cancer gets worse or they have any serious side effects.
REC name
HSC REC A
REC reference
23/NI/0160
Date of REC Opinion
11 Jan 2024
REC opinion
Further Information Favourable Opinion