60 Participants Needed

Hormone Therapy for Male Breast Cancer

Recruiting at 7 trial locations
JP
Overseen ByJose Pablo Leone, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Jose Pablo Leone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Tamoxifen, a common hormone therapy for male breast cancer, is associated with a high rate of treatment-limiting symptoms. Anastrozole, another hormone therapy, has been used without adverse events in some cases, but more research is needed to fully understand its safety in men.12345

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?

JP

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

I can take pills by mouth.
I am willing to have a breast biopsy after the initial treatment phase.
I have had ductal or lobular carcinoma in situ in either breast.
See 8 more

Exclusion Criteria

The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
I currently have an active infection (bacterial, fungal, or viral).
I have been diagnosed with inflammatory breast cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Window Phase

Participants receive endocrine therapy for 3 weeks to evaluate initial response

3 weeks
1 visit (in-person)

Treatment

Participants receive one of four endocrine therapy treatment combinations for 4 months

4 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
2 visits (in-person)

Long-term Follow-up

Participants are followed for up to 10 years to monitor long-term outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Abemaciclib
  • Anastrozole
  • Degarelix
  • Tamoxifen
Trial Overview The ETHAN study tests how male breast cancer responds to preoperative endocrine therapy. It compares the effectiveness of Tamoxifen, Anastrozole, Degarelix, and Abemaciclib in treating this condition before surgery.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Window Phase Arm C: Anastrozole + DegarelixExperimental Treatment2 Interventions
Group II: Window Phase Arm B: AnastrozoleExperimental Treatment1 Intervention
Group III: Window Phase Arm A: TamoxifenExperimental Treatment1 Intervention
Group IV: Neoadjuvant Phase Arm G: Anastrozole + Degarelix + AbemaciclibExperimental Treatment3 Interventions
Group V: Neoadjuvant Phase Arm F: Anastrozole and DegarelixExperimental Treatment2 Interventions
Group VI: Neoadjuvant Phase Arm E: Tamoxifen + AbemaciclibExperimental Treatment2 Interventions
Group VII: Neoadjuvant Phase Arm D: TamoxifenExperimental Treatment1 Intervention

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Verzenio for:
🇪🇺
Approved in European Union as Verzenio for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jose Pablo Leone

Lead Sponsor

Trials
1
Recruited
60+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

Trials
1
Recruited
60+

Published Research Related to This Trial

Male breast cancer is rare, occurring at about 1% of the rate of female breast cancer, and is often highly positive for hormone receptors, making hormone therapy the primary treatment.
For advanced cases, treatments like tamoxifen and orchiectomy are common, while newer hormonal therapies show promise but require further study to confirm their effectiveness in male breast cancer.
Pharmacotherapy for male breast cancer.Hayes, T.[2019]
A study comparing 49 male breast cancer patients to 680 postmenopausal female patients found that while male tumors were generally smaller at diagnosis, both groups had similar survival outcomes and prognostic factors, indicating comparable disease characteristics.
However, male patients experienced a higher drop-out rate from adjuvant endocrine therapy (16.3% vs. 7.6% in females), primarily due to side effects, highlighting a need for better management of treatment tolerability in male breast cancer.
Clinical, Pathological, and Prognostic Features of Male Breast Cancer: A Multicenter Study.Accomasso, F., Actis, S., Minella, C., et al.[2023]
Male breast cancer (MBC) is becoming more common in the U.S., but mortality rates have not improved, highlighting a need for better understanding and treatment strategies specific to MBC.
Current treatments for MBC, primarily hormonal therapies like tamoxifen, are often based on female breast cancer protocols, despite significant biological differences between the two, suggesting that tailored approaches are necessary for effective management.
Hormonal therapy for male breast cancer: A different approach for a different disease.Nahleh, ZA.[2022]

Citations

Pharmacotherapy for male breast cancer. [2019]
Clinical, Pathological, and Prognostic Features of Male Breast Cancer: A Multicenter Study. [2023]
Hormonal therapy for male breast cancer: A different approach for a different disease. [2022]
[Systemic therapy of male breast cancer]. [2018]
A role for the androgen receptor in the treatment of male breast cancer. [2016]
Exploratory study of drug plasma levels during bicalutamide 150 mg therapy co-administered with tamoxifen or anastrozole for prophylaxis of gynecomastia and breast pain in men with prostate cancer. [2018]
Tamoxifen administration is associated with a high rate of treatment-limiting symptoms in male breast cancer patients. [2022]
Treatment of bicalutamide-induced breast events. [2014]
Potential benefit of maintenance trastuzumab and anastrozole therapy in male advanced breast cancer. [2018]
Aromatase inhibitors and male breast cancer. [2019]
How to treat male breast cancer. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Male breast cancer. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security