ETHAN - ET for Male BC

Launched by JOSE PABLO LEONE · Aug 12, 2022

Keywords

ClinConnect Summary

The ETHAN trial is a research study aimed at understanding how well different preoperative treatments work for men with breast cancer. Specifically, it is looking at how effective various endocrine therapies (hormonal treatments) are in treating male breast cancer before surgery. The drugs being tested include Tamoxifen, Anastrozole, Degarelix, and Abemaciclib. This study is currently recruiting participants who are men aged 18 or older and have been diagnosed with invasive breast cancer that has not yet been surgically removed. They must have hormone receptor-positive, HER2-negative breast cancer, and can have either early-stage or more advanced cancer.

To participate, men must meet certain health criteria, including having adequate blood counts and organ function. They should not have received any prior treatments for their current breast cancer or other serious health conditions that could interfere with the study. Participants will receive the assigned treatment and will be monitored closely throughout the study. They will also need to agree to use effective contraception if they have partners who could become pregnant. This trial is an important step in finding better treatments for male breast cancer, and participants can contribute to advancing medical knowledge in this area.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • HER2-negative is defined per the current American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline (113).
• • Patients with multifocal or multicentric disease are eligible if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.
• • Bilateral breast cancers are allowed if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.
• • Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.
• • ECOG performance status ≤ 2.
• * Required laboratory values demonstrating adequate organ function:
• • ANC ≥ 1000/mm3
• • Hemoglobin ≥ 8 g/dl
• • Platelets ≥ 50,000/mm3
• • Serum creatinine ≤ 3.0 x ULN (institutional)
• • Total bilirubin ≤ 2.0 x ULN (institutional).
• • AST and ALT ≤ 5.0 x ULN (institutional)
• • Men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 6 months after the last dose of study treatment.
• • Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.
• • Willing and able to sign informed consent.
• • Willing to undergo breast biopsy after completion of window phase.
• • Patient is able to swallow oral medications.
• Exclusion Criteria:
• • 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.
• • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
• • The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
• • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.