Health Trials

ETHAN - ET for Male BC

ConditionsMale Breast CancerHormone Receptor-positive Breast CancerHormone Receptor Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorJose Pablo Leone

About this trial

This research study is looking to see how well male breast cancer responds to preoperative treatment with endocrine therapy and which endocrine therapy regimen is the most effective treatment for male breast cancer.

The drugs used in this study are:

* Tamoxifen * Anastrozole * Degarelix * Abemaciclib

Eligibility criteria

Qualifiers

Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary nodes.

Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112).

Breast cancer must be hormone receptor-positive and HER2-negative according to definition below assessed by local pathology.

Hormone receptor-positive is defined as: positivity for at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR]) by IHC. ER and PR assays are considered positive if there are > 1% positive tumor nuclei in the samples.

Disqualifiers

Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.

Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.

Diagnosis of inflammatory breast cancer (T4d).

Other concurrent serious diseases that may interfere with planned treatment, including severe cardiac disease, congestive heart failure (CHF) of New York Heart Association (NYHA) Class III or higher, severe pulmonary conditions/illness, uncontrolled infections.

Trial design

Treatments tested in this trial

  • Tamoxifen
  • Anastrozole
  • Degarelix
  • Abemaciclib

Treatment groups

60 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Jose Pablo Leone

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Eli Lilly and Company

Collaborator

Translational Breast Cancer Research Consortium (TBCRC)

Collaborator

Source ClinicalTrials.gov