RecruitingPhase 2

ETHAN - ET for Male BC

ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility and study treatment including laboratory evaluations and quality of life questionnaires."
  • "After completion of treatment, participants will be followed for up to 10 years It is expected that about 60 men will take part in this research study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well hormone therapy works before surgery for men with breast cancer and which treatment plan works best. It is for adult men with stage I, II, or III breast cancer that responds to hormones and is HER2-negative. The study drugs are tamoxifen, anastrozole, degarelix, and abemaciclib.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older with invasive breast cancer, meaning cancer that has grown into nearby breast tissue. The breast tumor and underarm lymph nodes must not have been removed by surgery.
  • Cancer must be stage I, II, or III, respond to estrogen or progesterone hormones, and be HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Cancer in several breast areas or both breasts is allowed if the study doctor says it should be treated as estrogen-responsive and HER2-negative. Past DCIS or LCIS, abnormal cells within breast ducts or milk glands, is allowed.
  • Must be able to care for yourself and be out of bed or a chair for more than half of waking hours.
  • Blood counts and kidney and liver test results must meet study limits.
  • If your partner could become pregnant, you and/or your partner must use one highly effective or two effective non-hormonal birth control methods during treatment and for 6 months afterward.
  • Must agree to join, sign a consent form, swallow pills, and have a breast biopsy—a small tissue sample taken—after the study's first treatment phase.
  • You do not need to speak English. People who do not speak English will not need to fill out study questionnaires.

Who can't join

  • Any past hormone therapy, chemotherapy, radiation, or experimental treatment for the current breast cancer.
  • Hormone therapy, treatment that reaches the whole body, radiation, or experimental treatment for another cancer within the past 12 months.
  • Inflammatory breast cancer, a type listed as stage T4d.
  • Serious or uncontrolled illness that could interfere with treatment, such as severe heart or lung disease, heart failure, uncontrolled infection, or severe kidney problems.
  • Certain bowel conditions, including Crohn's disease, ulcerative colitis, ongoing moderate or worse diarrhea, or past major surgery removing part of the stomach or small bowel.
  • An active bacterial infection needing antibiotics through a vein when treatment starts, a fungal infection, or a detectable viral infection such as HIV or active hepatitis B or C. Screening is not required to join.
  • A history of fainting caused by a heart problem, dangerous rhythms in the heart's lower chambers, or sudden cardiac arrest, when the heart stops beating.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (9)

DC

FL

MA

  • Dana Farber Cancer Institute · Boston, MA 02115Jose Pablo Leone, MD · Study contact · 617-789-2903Jose Pablo Leone, MD · Principal investigatorMore trials in Boston

MN

NC

PA

TN

TX

  • M. D. Anderson Cancer Center at University of Texas · Houston, TX 77030-4009Clinical Trials Office - M. D. Anderson Cancer Center at the U · Study contact · 713-792-3245Jasmine Sukumar, M.D · Principal investigatorMore trials in Houston