Ph3Study in Patients with Locally Advanced or Metastatic Breast Cancer
Research type
Research Study
Full title
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane
IRAS ID
234521
Contact name
Stephen Chan
Contact email
Sponsor organisation
Odonate Therapeutics, LLC
Eudract number
2017-002961-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
062584, IND Number
Duration of Study in the UK
5 years, 5 months, 6 days
Research summary
This study is a multinational, multicentre, randomised Phase III study designed to assess the efficacy, safety and tolerability of tesetexel plus a reduced dose of carbecitabine versus carbecitabine alone in patients with HER2 negative, hormone receptor positive, locally advanced or metastatic breast cancer previously treated with a taxane.
Approximately 625 male and female patients aged 18 years or over will be enrolled in this study worldwide.
Participants could potentially take part in this study for up to 61 months (including screening), depending on disease progression; however, it is expected that, on average, participants will be treated on the study for about 48 weeks. Patients will be treated until documentation of progressive disease, evidence of unacceptable toxicity, or other decision to discontinue treatment.
Participants will be followed for response and progression-free survival until documented disease progression or initiation of non-Study treatment for breast cancer.
In the event of disease progression or initiation of non-Study treatment for breast cancer, participants will be followed for overall survival and subsequent cancer treatment information every 3 months, for up to 60 months, from the date of Randomisation, unless lost to follow-up, death, or Study closure.
There will be two treatment groups for this study, one group will receive tesetexel plus a reduced dose of capecitabine, and the other group will receive capecitabine alone. The dose of tesetexel will be calculated based on the body surface area of the participant. Participants will be randomly assigned to one of these two groups on a 1:1 basis.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0003
Date of REC Opinion
15 Feb 2018
REC opinion
Further Information Favourable Opinion