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.
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
- Conditions the study is for
- Male Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma
- What is being tested?
- Tamoxifen, Anastrozole and Degarelix
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
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- 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.
9 sites in 1 country
United States9 sites, 9 recruiting
- 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
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).
- Conditions
- Male Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Window Phase Arm A: Tamoxifen | Experimental | Participants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days). Receives: Drug: Tamoxifen |
| Window Phase Arm B: Anastrozole | Experimental | Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days). Receives: Drug: Anastrozole |
| Window Phase Arm C: Anastrozole + Degarelix | Experimental | Participants 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: Tamoxifen | Experimental | Participants 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 + Abemaciclib | Experimental | 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. Receives: Drug: Tamoxifen; Drug: Abemaciclib |
| Neoadjuvant Phase Arm F: Anastrozole and Degarelix | Experimental | 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. Receives: Drug: Anastrozole; Drug: Degarelix |
| Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib | Experimental | 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. Receives: Drug: Anastrozole; Drug: Degarelix; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
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
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
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.
- First posted15 Aug 2022
- Study start11 Oct 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jose Pablo Leone
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Translational Breast Cancer Research Consortium
- Responsible party
- Sponsor-investigator, Jose Pablo Leone, Dana-Farber Cancer Institute
- Investigators
- Jose Pablo Leone, MD, Principal investigator, Dana-Farber Cancer Institute
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.