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Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

NCT02676986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2024-07-05

No results posted yet for this study

Summary

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of 15 days and a maximum of 29 days unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial.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.

Conditions

  • Primary Breast Cancer ER+ve
  • Primary Breast Cancer AR+ve TNBN

Interventions

DRUG

Enzalutamide

Anti-androgen

DRUG

Exemestane

Hormonal therapy (Licenced)

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Peter Schmid · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-10
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States
  • Germany
  • Ireland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676986 on ClinicalTrials.gov