673-201 Study of BMN 673 in patients with Germline BRCA mutation
Research type
Research Study
Full title
A Phase 2, 2-Stage, 2-Cohort Study of BMN 673 Administered to Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer
IRAS ID
151253
Contact name
Nicholas Turner
Contact email
Sponsor organisation
BioMarin Pharmaceuticals Inc.
Eudract number
2013-003076-12
Clinicaltrials.gov Identifier
Research summary
This is an open label, phase 2, 2 cohort study of BMN 673 for patients with locally advanced or metastatic breast cancer and harmful BRCA mutations (a change in the gene sequence).
Up to 140 participants will take part at approximately 40 international sites. Participants will be assigned to either Cohort 1 or 2 based on previous chemotherapy for metastatic (cancer that has spread to other parts of the body) disease.
Cohort 1: Participants who have responded to platinum containing treatment for metastatic disease with disease progression of more than 8 weeks after the last dose of platinum.
Cohort 2: Participants who have had no previous platinum treatment for metastatic disease but have received more than 2 chemotherapy treatments before.
During the trial, patients will attend a screening visit within 28 days of the first dose of treatment (Cycle 1,Day 1) and a baseline visit within 7 days of cycle 1, Day 1). Patients will be expected to attend weekly site visits for the first 3 cycles of BMN 673, they will continue with treatment until disease progression,unacceptable toxicity, withdrawal of consent, Investigator decision to terminate treatment, or sponsor’s decision to terminate the trial. During visits the following study procedures will be performed: blood tests, urine tests, CT or MRI scans and several other examinations and procedures.Patients will also complete questionnaires about their quality of life.
It is hoped that the results of this study will help in the development of an effective alternative treatment option for breast cancer patients with germline BRCA1 or BRCA2 mutation.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0855
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion