Trial Title:
ETHAN - ET for Male BC
NCT ID:
NCT05501704
Condition:
Male Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Breast Neoplasms, Male
Tamoxifen
Anastrozole
Conditions: Keywords:
Male Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
Taken orally
Arm group label:
Neoadjuvant Phase Arm D: Tamoxifen
Arm group label:
Neoadjuvant Phase Arm E: Tamoxifen + Abemaciclib
Arm group label:
Window Phase Arm A: Tamoxifen
Other name:
Nolvadex
Other name:
Soltamox
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
Taken orally
Arm group label:
Neoadjuvant Phase Arm F: Anastrozole and Degarelix
Arm group label:
Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib
Arm group label:
Window Phase Arm B: Anastrozole
Arm group label:
Window Phase Arm C: Anastrozole + Degarelix
Other name:
Arimidex
Intervention type:
Drug
Intervention name:
Degarelix
Description:
Subcutaneous (under the skin) injection
Arm group label:
Neoadjuvant Phase Arm F: Anastrozole and Degarelix
Arm group label:
Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib
Arm group label:
Window Phase Arm C: Anastrozole + Degarelix
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Taken orally
Arm group label:
Neoadjuvant Phase Arm E: Tamoxifen + Abemaciclib
Arm group label:
Neoadjuvant Phase Arm G: Anastrozole + Degarelix + Abemaciclib
Other name:
Verzenio
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
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgetown University Medical Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office Breast Cancer
Phone:
202-444-2223
Contact backup:
Last name:
Elaine Walsh, MD
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose Pablo Leone, MD
Phone:
617-789-2903
Contact backup:
Last name:
Jose Pablo Leone, MD
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Trials Referral Office
Phone:
855-776-0015
Contact backup:
Last name:
Kathryn Ruddy, MD
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Peter Voorhees, MD
Phone:
9199665879
Email:
peter_voorhees@med.unc.edu
Contact backup:
Last name:
Peter Voorhees, MD
Facility:
Name:
M. D. Anderson Cancer Center at University of Texas
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - M. D. Anderson Cancer Center at the U
Phone:
713-792-3245
Contact backup:
Last name:
Jasmine Sukumar, M.D
Start date:
October 11, 2023
Completion date:
April 1, 2036
Lead sponsor:
Agency:
Jose Pablo Leone
Agency class:
Other
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Collaborator:
Agency:
Translational Breast Cancer Research Consortium (TBCRC)
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501704
