Primary Breast Cancer AR+ve TNBN Clinical Trial
Official title:
Phase II Window of Opportunity Study of Short-term Preoperative Treatment With Enzalutamide (Alone or in Combination With Exemestane) in Patients With Primary Breast Cancer
Open-label, international, multicentre window of opportunity phase II trial to evaluate the
effects of short-term preoperative therapy with enzalutamide (alone or in combination with
exemestane) in women with newly diagnosed invasive primary breast cancer. The study has two
cohorts:
- ER+ve breast cancer
- AR+ve, Triple-negative (i.e. ER-negative, PR-negative and HER2-negative) breast cancer
Study treatment is planned for a minimum of 15 days and a maximum of 29 days unless there is
evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial.
Thereafter, patients will either be considered for definitive surgery or primary medical
treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician.
The effects of enzalutamide (alone or in combination with exemestane) will be assessed on
tumour tissue specimens taken at baseline and on the last day of study treatment.
n/a