AzTrials
AzTrials

Male Breast CancerPhase 2NCT05501704

ETHAN - ET for Male BC

A Phase 2 study testing Tamoxifen, Anastrozole and Degarelix in people with Male Breast Cancer and Hormone Receptor-positive Breast Cancer, run by Jose Pablo Leone at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Tamoxifen, Anastrozole and Degarelix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
9 sitesUnited States
Study dates
11 Oct 2023to 1 Apr 2036
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary nodes.
  • Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112).
  • Breast cancer must be hormone receptor-positive and HER2-negative according to definition below assessed by local pathology.
  • Hormone receptor-positive is defined as: positivity for at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR]) by IHC. ER and PR assays are considered positive if there are > 1% positive tumor nuclei in the samples.
  • HER2-negative is defined per the current American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline (113).
  • Patients with multifocal or multicentric disease are eligible if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.
Show all 21Show fewer
  • Bilateral breast cancers are allowed if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.
  • Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.
  • ECOG performance status ≤ 2.
  • Required laboratory values demonstrating adequate organ function:
  • ANC ≥ 1000/mm3
  • Hemoglobin ≥ 8 g/dl
  • Platelets ≥ 50,000/mm3
  • Serum creatinine ≤ 3.0 x ULN (institutional)
  • Total bilirubin ≤ 2.0 x ULN (institutional).
  • AST and ALT ≤ 5.0 x ULN (institutional)
  • Men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 6 months after the last dose of study treatment.
  • Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.
  • Willing and able to sign informed consent.
  • Willing to undergo breast biopsy after completion of window phase.
  • Patient is able to swallow oral medications.

Who cannot join

  • Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.
  • Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.
  • Diagnosis of inflammatory breast cancer (T4d).
  • Other concurrent serious diseases that may interfere with planned treatment, including severe cardiac disease, congestive heart failure (CHF) of New York Heart Association (NYHA) Class III or higher, severe pulmonary conditions/illness, uncontrolled infections.
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jose Pablo Leone, MD contact

617-789-2903

josep_leone@dfci.harvard.edu

9 sites in 1 country

United States9 sites, 9 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Jose Pablo Leone, MD, 617-789-2903

    Jose Pablo Leone, MD

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Yara Abdou, MD, yara_abdou@med.unc.edu

    Yara Abdou, MD

    Recruiting

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

    Clinical Trials Office - M. D. Anderson Cancer Center at the U, 713-792-3245

    Jasmine Sukumar, M.D

    Recruiting

  • Mayo Clinical Hospital Florida

    Jacksonville, Florida, 32224

    Mayo Clinic Cancer Center, 904-953-2000, Klosowski.angelica@mayo.edu

    904-953-7610, stark.emily@mayo.edu

    Recruiting

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232

    Kathy G Taylor, 6153222064, Kathy.l.taylor@vumc.org

    Jessica Sharpe, 615.875.0060, jessica.m.sharpe@vumc.org

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Igor Makhlin, MD, igor.makhlin@pennmedicine.upenn.edu

    Igor Makhlin, MD

    Recruiting

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

    Rometa Kerney, (412) 641-5430, pollardrr@upmc.edu

    Priscilla McAuliffe, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Cancer Trials Referral Office, 855-776-0015

    Kathryn Ruddy, MD

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Clinical Trials Office Breast Cancer, 202-444-2223

    Elaine Walsh, MD

    Recruiting

Other trials in United States

About this study

Official title: ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer

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
Read the detailed description

This is an open-label, multicenter, randomized trial for men with stage I-III hormone receptor-positive (HR+)/HER2-negative breast cancer. The trial will have two phases: 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.

Tamoxifen is the standard of care for the treatment of breast cancer in men. Anastrozole is a standard treatment in women with breast cancer and works more effectively than tamoxifen. This study hopes to learn if anastrozole may also be effective in men. Given that gonadal suppression and CDK 4/6 inhibitors have both improved treatment in women with breast cancer, the study hopes to learn how the addition of Degarelix (gonadal suppression) and Abemaciclib (CDK 4/6 inhibitors) work in comparison to standard of care tamoxifen.

The research study procedures include screening for eligibility and study treatment including laboratory evaluations and quality of life questionnaires.

After completion of treatment, participants will be followed for up to 10 years

It is expected that about 60 men will take part in this research study.

Eli Lilly, a pharmaceutical company, is supporting this research study by providing one of the study drugs. This study is also being supported by Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC).

Being tested
Tamoxifen, Anastrozole, Degarelix, Abemaciclib
Keywords
Male Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Negative Breast Cancer
Medical subject headings
Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

    Also called Nolvadex, Soltamox

    Taken orally

  • AnastrozoleDrug

    Also called Arimidex

    Taken orally

  • DegarelixDrug

    Subcutaneous (under the skin) injection

  • AbemaciclibDrug

    Also called Verzenio

    Taken orally

Study groups in NCT05501704
Study groupRoleWhat they receive
Window Phase Arm A: TamoxifenExperimentalParticipants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days).
Receives: Drug: Tamoxifen
Window Phase Arm B: AnastrozoleExperimentalParticipants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days).
Receives: Drug: Anastrozole
Window Phase Arm C: Anastrozole + DegarelixExperimentalParticipants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days) and Degarelix on day 1 only.
Receives: Drug: Anastrozole; Drug: Degarelix
Neoadjuvant Phase Arm D: TamoxifenExperimentalParticipants will be randomly assigned to receive Tamoxifen 1x daily for 4 cycles (4 months); each study cycle is 28 days.
Receives: Drug: Tamoxifen
Neoadjuvant Phase Arm E: Tamoxifen + AbemaciclibExperimentalParticipants will be randomly assigned to receive Tamoxifen 1x daily and Abemaciclib 2x daily for 4 cycles (4 months); each study cycle is 28 days.
Receives: Drug: Tamoxifen; Drug: Abemaciclib
Neoadjuvant Phase Arm F: Anastrozole and DegarelixExperimentalParticipants 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.
Receives: Drug: Anastrozole; Drug: Degarelix
Neoadjuvant Phase Arm G: Anastrozole + Degarelix + AbemaciclibExperimentalParticipants 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.
Receives: Drug: Anastrozole; Drug: Degarelix; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ki-67

    Ki-67 will be evaluated by ImmunoHistoChemistry (IHC) following consensus recommendations using imaging analysis methods.

    Measured: At the end of the 3-week window period.

  2. RCB index

    RCB will be determined using data from each participating institution pathology department, and will be reviewed by the study team pathologist.

    Measured: At time of surgery.

Secondary outcomes (3)

  1. Changes in estradiol levels

    To evaluate the physiologic endocrine changes that occur as a result of treatment with tamoxifen, anastrozole and anastrozole and degarelix as measured by estradiol levels at baseline and at the end of the three-week window period

    Measured: Baseline and at the end of the three-week window period

  2. Changes in testosterone levels

    To evaluate the physiologic endocrine changes that occur as a result of treatment with tamoxifen, anastrozole and anastrozole and degarelix as measured by testosterone levels at baseline and at the end of the three-week window period

    Measured: Baseline and at the end of the three-week window period

  3. Preoperative Endocrine Prognostic Index (PEPI) score

    To evaluate the comparative efficacy of the experimental treatments as measured by PEPI score at surgery.

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start11 Oct 2023
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501704
Sponsor's protocol ID
22-225
Status last verified
Aug 2026
First submitted
10 Aug 2022
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tamoxifen, Anastrozole and Degarelix in people with Male Breast Cancer and Hormone Receptor-positive Breast Cancer, run by Jose Pablo Leone at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose Pablo Leone, MD (617-789-2903, josep_leone@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ki-67 (time frame: At the end of the 3-week window period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05501704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in