Hormone Therapy for Male Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have been on any endocrine therapy, chemotherapy, or radiation therapy for breast cancer or any other cancer in the past 12 months, you would not be eligible to participate.
Is hormone therapy for male breast cancer generally safe?
How does the drug combination of Abemaciclib, Anastrozole, Degarelix, and Tamoxifen differ from other treatments for male breast cancer?
This drug combination is unique because it includes Abemaciclib, a newer drug that targets specific proteins involved in cell division, alongside traditional hormone therapies like Tamoxifen and Anastrozole, which are commonly used in female breast cancer but less studied in males. This approach may offer a novel way to address the hormone receptor-positive nature of most male breast cancers.16789
What data supports the effectiveness of the drug Abemaciclib, Verzenio, LY2835219, Ramiven, Abemaciclib, Anastrozole, Arimidex, Degarelix, Firmagon, Tamoxifen, Nolvadex, Tamoxifen citrate for male breast cancer?
Hormone therapy, including drugs like Tamoxifen, is commonly used for male breast cancer due to the high rate of hormone receptor positivity in these tumors. Although specific data on newer drugs like Abemaciclib and Anastrozole in male breast cancer is limited, they are used based on their effectiveness in female breast cancer, which shares similar hormone receptor characteristics.79101112
Who Is on the Research Team?
Jose Pablo Leone, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for men aged 18+ with invasive breast cancer that's hormone receptor-positive and HER2-negative, who haven't had surgery yet. Participants must be able to take oral meds, have certain organ function levels, and use contraception if with a partner of childbearing potential. Excluded are those with serious medical conditions, active infections, inflammatory breast cancer or recent treatments for other cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Window Phase
Participants receive endocrine therapy for 3 weeks to evaluate initial response
Treatment
Participants receive one of four endocrine therapy treatment combinations for 4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are followed for up to 10 years to monitor long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Anastrozole
- Degarelix
- Tamoxifen
Abemaciclib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jose Pablo Leone
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Translational Breast Cancer Research Consortium (TBCRC)
Collaborator