ETHAN - ET for Male BC

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Jose Pablo Leone
Study ID
NCT05501704
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hormone Receptor Negative Breast Carcinoma
  • Hormone Receptor-positive Breast Cancer
  • Male Breast Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen — DRUG
    Taken orally
  • Anastrozole — DRUG
    Taken orally
  • Degarelix — DRUG
    Subcutaneous (under the skin) injection
  • Abemaciclib — DRUG
    Taken orally

Study Details

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

Key Dates

Start date
Oct 11, 2023
Status verified
Dec 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2036

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Window Phase Arm A: Tamoxifen
    Participants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days).
  • Experimental: Window Phase Arm B: Anastrozole
    Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days).
  • Experimental: Window Phase Arm C: Anastrozole + Degarelix
    Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days) and Degarelix on day 1 only.
  • Experimental: Neoadjuvant Phase Arm D: Tamoxifen
    Participants will be randomly assigned to receive Tamoxifen 1x daily for 4 cycles (4 months); each study cycle is 28 days.
  • Experimental: Neoadjuvant Phase Arm E: Tamoxifen + Abemaciclib
    Participants will be randomly assigned to receive Tamoxifen 1x daily and Abemaciclib 2x daily for 4 cycles (4 months); each study cycle is 28 days.
  • Experimental: Neoadjuvant Phase Arm F: Anastrozole and Degarelix
    Participants will be randomly assigned to receive Anastrozole 1x daily and Degarelix on day 1 of each cycle for 4 cycles (4 months); each study cycle is 28 days.
  • Experimental: Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib
    Participants will be randomly assigned to receive Anastrozole 1x daily, Degarelix on day 1 of each cycle and Abemaciclib 2x daily for 4 cycles (4 months); each study cycle is 28 days.

Primary Outcome Measure

Change in Ki-67 [ Time Frame: At the end of the 3-week window period. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Clinical Trials Office Breast Cancer
202-444-2223
Elaine Walsh, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Jose Pablo Leone, MD
617-789-2903
Jose Pablo Leone, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Cancer Trials Referral Office
855-776-0015
Kathryn Ruddy, MD (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Yara Abdou, MD
[email protected]
Yara Abdou, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104
Igor Makhlin, MD
[email protected]
Igor Makhlin, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232
Rometa Kerney
[email protected]
(412) 641-5430
Priscilla McAuliffe, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt Cancer CenterNashvilleTennessee37232
Kathy G Taylor
[email protected]
6153222064
Jessica Sharpe
[email protected]
615.875.0060
Jessica Sharpe, MD (PRINCIPAL_INVESTIGATOR)
M. D. Anderson Cancer Center at University of TexasHoustonTexas77030-4009
Clinical Trials Office - M. D. Anderson Cancer Center at the U
713-792-3245
Jasmine Sukumar, M.D (PRINCIPAL_INVESTIGATOR)

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Georgetown University Medical Center· Washington D.C., DCDana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PAUniversity of Pittsburgh Cancer Institute· Pittsburgh, PA

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