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

Completed · Phase 2

Conditions studied: Primary Breast Cancer ER+ve, Primary Breast Cancer AR+ve TNBN

In brief

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of 15 days and a maximum of 29 days unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial.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

Key facts

Study ID

NCT02676986

Run by

Queen Mary University of London

People needed

221

Starts

2015-08-10

Expected to finish

2016-12-31

Last updated by the study team

2024-07-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Inflammatory breast cancer
• Treatment with any of the following medications within 4 weeks before the baseline diagnostic biopsy is taken:
• Oestrogens, including hormone replacement therapy;
• Androgens (testosterone, dihydroepiandrosterone, etc.);
• Any approved or investigational agent that blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700)
• Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments); prior treatment for previous breast cancer or other neoplasms is allowed as long as it was completed at least 1 year prior to inclusion into this trial.
• History of seizure or any condition that may predispose to seizure; history of loss of consciousness or transient ischemic attack within 12 months before day 1.
• Significant cardiovascular disease, such as
• History of myocardial infarction, acute coronary syndromes or coronary angioplasty/stenting/bypass grafting within the past 6 months.
• Congestive heart failure New York Heart Association (NYHA) Class III or IV or history of congestive heart failure NYHA class III or IV, unless an echocardiogram or multigated acquisition scan performed within 3 months before day 1 reveals a left ventricular ejection fraction ≥ 45%;
• History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes);
• Hypersensitivity to the active pharmaceutical ingredient or any of the excipients of the IMPs, including Labrasol, butylated hydroxyanisole, and butylated Hydroxytoluene
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an IMP, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
• Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 4 weeks prior to study entry.

Where it is running

• MD Anderson Cancer Centre — Houston, Texas, United States
• Evangelisches Krankenhaus Bergisch Gladbachg GmbH Frauenklinik — Bergisch Gladbach, Germany
• Charité Campus Mitte — Berlin, Germany
• Brustzentrum City St. Gertraudenkrankenhaus — Berlin, Germany
• Evangelisches Waldkrankenhaus Spandau — Berlin, Germany
• Johanniter Krankenhaus Bonn — Bonn, Germany
• Onkologische Schwerpunktpraxis Bremen — Bremen, Germany
• Klinikum Chemnitz GmbH — Chemnitz, Germany
• Brustzentrum Uniklinik Köln — Cologne, Germany
• St. Elisabeth Krankenhaus Köln — Cologne, Germany
• Brustzentrum Holweide — Cologne, Germany
• Kliniken-Essen-Mitte, Senology — Essen, Germany
• Agaplesion Markus Krankenhaus — Frankfurt, Germany
• Evangelische Kliniken Gelsenkirchen — Gelsenkirchen, Germany
• Hannover Diakovere Henriettenstift — Hannover, Germany
• Klinikum Kassel — Kassel, Germany
• Klinikum Kempten — Kempten, Germany
• UKSH -Campus Kiel — Kiel, Germany
• DRK Kliniken Berlin Köpenick — Köpenick, Germany
• UKSH Lübeck — Lübeck, Germany
• UKSH Lüneburg, Städtisches Krankenhaus — Lüneburg, Germany
• Johannes wesling Klinikum (Minden Hospital) — Minden, Germany
• Brustzentrum Niederrhein / ÜBAG Prof. Nitz Mönchengladbach — Mönchengladbach, Germany
• Onkologisches Zentrum am Rotkreuzklinikum München — München, Germany
• Helios-Kliniken Schwerin — Schwerin, Germany

Full record on ClinicalTrials.gov

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