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TBCRC-059: ETHAN: A phase II study comparing different Endocrine THerapies for mAle breast caNcer

This research study is looking to see 1) how well your breast cancer responds to preoperative treatment with endocrine therapy and 2) which endocrine therapy regimen is the most effective treatment for male breast cancer. The study includes a 3-week window phase containing endocrine therapy followed by a 4-month treatment phase where participants are treated with one of four endocrine therapy treatment combinations.

Age & Gender

  • 18 years ~ 99 years
  • Male, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

This research study involves pre-operative therapy that is specifically targeted for your type of breast cancer. You will be randomized, which means randomly assigned, to one of the treatment arms. In the 3-week window phase portion of the trial, the treatment arms and the study drugs in each arm are: • Arm A: Tamoxifen • Arm B: Anastrozole • Arm C: Anastrozole + Degarelix After completion of the 3-week window phase, a mandatory research biopsy will be done to determine how your cancer responded to the treatment. In the second phase of the study, the neoadjuvant phase, participants will be randomized to receive 4 months of treatment. Participants from Arm A of the window phase, will be randomized to one of the following treatment arms: • Arm D: Tamoxifen • Arm E: Tamoxifen + Abemaciclib Participants from arms B and C of the window phase will be randomized to one of the following treatments arms: • Arm F: Anastrozole + Degarelix • Arm G: Anastrozole + Degarelix + Abemaciclib After you complete study treatment, you will continue to surgery. The type of surgery you have will be decided by you and your Doctor. After surgery, we would like to keep track of your medical condition every year for up to 10 years.

Total length of participation:
Varies from 1 day to 10 years. Depending on how you respond to treatment.

Looking for Specific Volunteers

Able to participate:

  • You are a male diagnosed with invasive breast cancer and have not yet received surgery.
  • Your breast cancer is hormone receptor-positive and HER2-negative.
  • You are willing to undergo a breast biopsy after the first phase of the study.
  • You are able to swallow oral medications.

Not eligible if:

  • You have received treatment for your breast cancer.
  • You have received treatment for another cancer within the last 12 months.
  • You have a diagnosis of inflammatory breast cancer (T4d).
  • You have severe cardiac disease, congestive heart failure, severe pulmonary conditions or illnesses. Other concurrent serious diseases that may interfere with planned treatment, including severe
  • You have an active uncontrolled infection.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

24-0493

ClinicalTrials.gov

NCT05501704

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