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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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