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1

Hormone Therapy Before Surgery for Men with Stage I-III ER+, HER2- Breast Cancer

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

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) hormone therapy for male breast cancer.

Who is this for?: Men with newly diagnosed stage I, stage II, or stage III hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This trial has two parts. In part 1, you will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, 1 time</li> </ul> <p class="seamTextPara"> In part 2, you will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. Tamoxifen is the standard of care for the treatment of breast cancer in men.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow. Anastrozole is a standard treatment in women with breast cancer and works more effectively than tamoxifen.</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®) is approved to treat prostate cancer. It lowers the body's production of testosterone. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501704' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/22-225' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/degarelix.html' target='_blank'>Drugs.com: Degarelix (Firmagon®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
1

Hormone Therapy Before Surgery for Men with Stage I-III ER+, HER2- Breast Cancer

ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer
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Nearest Location from 12020:
148 miles
Dana Farber Cancer Institute
Boston, MA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05501704

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Phase II