BridgeMD
New treatment option for Male Breast Cancer
Official title ETHAN - ET for Male BC
ClinicalTrials.gov ID: NCT05501704
What this study is testing
What is Tamoxifen?
Tamoxifen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for male breast cancer.
Also referred to as Nolvadex, Soltamox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary...
- 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])...
- HER2-negative is defined per the current American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline (113).
You likely can't join if
- 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...
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation...
- The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection...
See the full eligibility 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%...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Chapel Hill, North Carolina, United States; Philadelphia, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.