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CDK4/6 Inhibitor
Hormone Therapy for Male Breast Cancer
Phase 2
Recruiting
Led By Jose Pablo Leone, MD
Research Sponsored by Jose Pablo Leone
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible
ECOG performance status ≤ 2
Must not have
The patient has active systemic bacterial infection, fungal infection, or detectable viral infection
Diagnosis of inflammatory breast cancer (T4d)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Summary
This trial is testing how well male breast cancer responds to different hormone therapies before surgery, to see which regimen is the most effective.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include hot flashes and mood swings from Tamoxifen; joint pain and osteoporosis from Anastrozole; injection site reactions from Degarelix; fatigue, diarrhea and low white blood cell counts from Abemaciclib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had ductal or lobular carcinoma in situ in either breast.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer is hormone receptor-positive and HER2-negative.
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My blood and organ function tests are within the required ranges.
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I am a man over 18 with invasive breast cancer and have not had surgery to remove the tumor or lymph nodes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have an active infection (bacterial, fungal, or viral).
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I have been diagnosed with inflammatory breast cancer.
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I have received treatments like hormone therapy, chemotherapy, or radiation for my current breast cancer.
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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.
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I haven't had cancer treatments or trials for other cancers in the last year.
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I do not have severe heart, lung conditions, or uncontrolled infections that could affect my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Ki-67
RCB index
Secondary study objectives
Changes in estradiol levels
Changes in testosterone levels
Preoperative Endocrine Prognostic Index (PEPI) score
Other study objectives
Adapted EORTC BR23 questionnaire
EORTC QLC-C30 questionnaire
Grade 3 or Higher Treatment-Related Toxicity Rate
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Window Phase Arm C: Anastrozole + DegarelixExperimental Treatment2 Interventions
Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days) and Degarelix on day 1 only.
Group II: Window Phase Arm B: AnastrozoleExperimental Treatment1 Intervention
Participants will be randomly assigned to receive Anastrozole 1x daily for 3 weeks (21days).
Group III: Window Phase Arm A: TamoxifenExperimental Treatment1 Intervention
Participants will be randomly assigned to receive Tamoxifen 1x daily for 3 weeks (21days).
Group IV: Neoadjuvant Phase Arm G: Anastrozole + Degarelix + AbemaciclibExperimental Treatment3 Interventions
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.
Group V: Neoadjuvant Phase Arm F: Anastrozole and DegarelixExperimental Treatment2 Interventions
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.
Group VI: Neoadjuvant Phase Arm E: Tamoxifen + AbemaciclibExperimental Treatment2 Interventions
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.
Group VII: Neoadjuvant Phase Arm D: TamoxifenExperimental Treatment1 Intervention
Participants will be randomly assigned to receive Tamoxifen 1x daily for 4 cycles (4 months); each study cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
2002
Completed Phase 3
~3730
Anastrozole
2016
Completed Phase 4
~5550
Tamoxifen
2005
Completed Phase 4
~30090
Abemaciclib
2019
Completed Phase 2
~1800
Find a Location
Who is running the clinical trial?
Jose Pablo LeoneLead Sponsor
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,584 Total Patients Enrolled
64 Trials studying Breast Cancer
36,697 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research Consortium (TBCRC)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I agree to use effective birth control during and for 6 months after the study.I currently have an active infection (bacterial, fungal, or viral).I have been diagnosed with inflammatory breast cancer.I can take care of myself but might not be able to do heavy physical work.I have cancer in both breasts, considered ER-positive and HER2-negative.My breast cancer is hormone receptor-positive and HER2-negative.I have received treatments like hormone therapy, chemotherapy, or radiation for my current breast cancer.My cancer is in multiple places but is considered ER-positive and HER2-negative.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I haven't had cancer treatments or trials for other cancers in the last year.I do not have severe heart, lung conditions, or uncontrolled infections that could affect my treatment.My blood and organ function tests are within the required ranges.I am a man over 18 with invasive breast cancer and have not had surgery to remove the tumor or lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Phase Arm F: Anastrozole and Degarelix
- Group 2: Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib
- Group 3: Neoadjuvant Phase Arm D: Tamoxifen
- Group 4: Neoadjuvant Phase Arm E: Tamoxifen + Abemaciclib
- Group 5: Window Phase Arm B: Anastrozole
- Group 6: Window Phase Arm A: Tamoxifen
- Group 7: Window Phase Arm C: Anastrozole + Degarelix
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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