Study on Endocrine Therapy for Male Breast Cancer (ETHAN)
Sponsor: Jose Pablo Leone
ClinicalTrials ID:NCT05501704
This clinical trial is exploring how well different hormone treatments work for men with breast cancer before surgery. The study aims to find the most effective treatment combination using drugs like Tamoxifen, Anastrozole, Degarelix, and Abemaciclib.
Patient Parameters
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Program Overview
The purpose of this study is to see how well male breast cancer responds to hormone treatments given before surgery and to find out which treatment works best. The study involves using drugs such as Tamoxifen, Anastrozole, Degarelix, and Abemaciclib. Participants will first receive a 3-week hormone treatment, followed by a 4-month treatment with one of four different hormone therapy combinations. The study will include regular health checks and quality of life assessments. After treatment, participants will be monitored for up to 10 years. About 60 men are expected to participate in this study, which is supported by Eli Lilly and Johns Hopkins University.
Description
This study is open to men with stage I-III hormone receptor-positive (HR+)/HER2-negative breast cancer. It will take place in multiple centers and involves two phases. In the first phase, participants will receive hormone therapy for 3 weeks. In the second phase, they will be treated for 4 months with one of four hormone therapy combinations.
Tamoxifen is commonly used to treat breast cancer in men, while Anastrozole is more effective in women. This study will test if Anastrozole is also effective for men. The study will also explore the effects of adding Degarelix, which suppresses hormones, and Abemaciclib, a CDK 4/6 inhibitor, to the treatment.
Participants will undergo screening to ensure they are eligible and will receive regular lab tests and complete quality of life questionnaires. After finishing the treatment, participants will be followed for up to 10 years to monitor their health.
The study is supported by Eli Lilly, which provides one of the study drugs, and Johns Hopkins University, representing the Translational Breast Cancer Research Consortium (TBCRC).
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older with invasive breast cancer who have not had surgery to remove the tumor or lymph nodes.
- Cancer must be stage I, II, or III according to specific medical guidelines.
- Cancer must be hormone receptor-positive and HER2-negative, meaning it has certain markers that respond to hormone therapy.
- Patients with multiple tumors or cancer in both breasts can participate if the cancer is hormone receptor-positive and HER2-negative.
- Patients with a history of certain non-invasive breast conditions are eligible.
- Must have a performance status score of 2 or lower, indicating they are able to carry out daily activities.
- Must have adequate organ function based on specific blood test results.
- Men with partners who can become pregnant must use effective non-hormonal birth control during the study and for 6 months after.
- Non-English speakers can participate but will not complete certain questionnaires.
- Must be willing to sign informed consent and undergo a breast biopsy after the initial treatment phase.
- Must be able to swallow pills.
Exclusion Criteria
- Have received hormone therapy, chemotherapy, radiation, or experimental treatment for the current breast cancer.
- Have received similar treatments for any other cancer within the past year.
- Have inflammatory breast cancer.
- Have serious health conditions that could interfere with treatment, such as severe heart or lung disease, uncontrolled infections, or severe kidney problems.
- Have active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.
- Have a history of certain heart conditions, such as fainting due to heart issues or abnormal heart rhythms.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Georgetown University Medical Center | 20007 | Washington | District of Columbia |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| University of Pennsylvania, Abramson Cancer Center | 19104 | Philadelphia | Pennsylvania |
| University of Pittsburgh Cancer Institute | 15232 | Pittsburgh | Pennsylvania |
| M. D. Anderson Cancer Center at University of Texas | 77030-4009 | Houston | Texas |
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