Male Breast CancerHormone Receptor-positive Breast CancerHormone Receptor Negative Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Jose Pablo Leone · Other
Who this trial is looking for
This trial is looking for men with breast cancer who have not had surgery yet. Participants will receive treatment to see how well it works before surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am a man aged 18 or older.
I have been diagnosed with invasive breast cancer.
I have hormone receptor-positive and HER2-negative breast cancer.
I have not had surgery for my breast cancer.
I have adequate organ function.
I am willing to use effective contraception if my partner can have children.
I can sign informed consent.
I can swallow oral medications.
You may not be able to join if
I have had prior treatment for my breast cancer.
I have inflammatory breast cancer.
I have serious health issues that interfere with treatment.
I have an active serious infection.
I have personal history of serious heart conditions.
I have had treatment for any other malignancy in the past 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 hormon…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.