RECRUITING

ETHAN - ET for Male BC

Conditions

Male Breast Cancer Hormone Receptor-positive Breast Cancer Hormone Receptor Negative Breast Carcinoma Hormone Receptor Negative Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

ETHAN: a Phase II Study Comparing Different Endocrine THerapies for MAle Breast CaNcer

Quick Facts

Study Start:2023-10-11

Study Completion:2036-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05501704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Jose Pablo Leone, MD

CONTACT

617-789-2903

josep_leone@dfci.harvard.edu

Principal Investigator

Jose Pablo Leone, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Georgetown University Medical Center

Washington, District of Columbia, 20007

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009

United States

Collaborators and Investigators

Sponsor: Jose Pablo Leone

Jose Pablo Leone, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11

Study Completion Date2036-04-01

Study Record Updates

Study Start Date2023-10-11

Study Completion Date2036-04-01

Terms related to this study

Keywords Provided by Researchers

Male Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Cancer

Additional Relevant MeSH Terms

Male Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Carcinoma