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ETHAN - ET for Male BC

ConditionsMale Breast CancerHormone Receptor-positive Breast CancerHormone Receptor Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorJose Pablo Leone

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamoxifen

    Drug

    Taken orally

  • Anastrozole

    Drug

    Taken orally

  • Degarelix

    Drug

    Subcutaneous (under the skin) injection

  • Abemaciclib

    Drug

    Taken orally

Treatment groups

60 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Window Phase Arm A: TamoxifenExperimental treatment 1 intervention
Group B: Window Phase Arm B: AnastrozoleExperimental treatment 1 intervention
Group C: Window Phase Arm C: Anastrozole + DegarelixExperimental treatment 2 interventions
Group D: Neoadjuvant Phase Arm D: TamoxifenExperimental treatment 1 intervention
Group E: Neoadjuvant Phase Arm E: Tamoxifen + AbemaciclibExperimental treatment 2 interventions
Group F: Neoadjuvant Phase Arm F: Anastrozole and DegarelixExperimental treatment 2 interventions
Group G: Neoadjuvant Phase Arm G: Anastrozole + Degarelix + AbemaciclibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in Ki-67

Ki-67 will be evaluated by ImmunoHistoChemistry (IHC) following consensus recommendations using imaging analysis methods.

Time frame
At the end of the 3-week window period.
2

RCB index

RCB will be determined using data from each participating institution pathology department, and will be reviewed by the study team pathologist.

Time frame
At time of surgery.

Secondary outcomes

1

Changes in estradiol levels

To evaluate the physiologic endocrine changes that occur as a result of treatment with tamoxifen, anastrozole and anastrozole and degarelix as measured by estradiol levels at baseline and at the end of the three-week window period

Time frame
Baseline and at the end of the three-week window period
2

Changes in testosterone levels

To evaluate the physiologic endocrine changes that occur as a result of treatment with tamoxifen, anastrozole and anastrozole and degarelix as measured by testosterone levels at baseline and at the end of the three-week window period

Time frame
Baseline and at the end of the three-week window period
3

Preoperative Endocrine Prognostic Index (PEPI) score

To evaluate the comparative efficacy of the experimental treatments as measured by PEPI score at surgery.

Time frame
At time of surgery

Other outcomes

1

Grade 3 or Higher Treatment-Related Toxicity Rate

All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.

Time frame
Up to 6 months
2

Trial enrollment

We will evaluate how many patients we are able to enroll to this trial in a period of 3 years

Time frame
3 years
3

Trial completion

We will evaluate how many of the enrolled participants successfully complete the study protocol

Time frame
3 years
4

EORTC QLC-C30 questionnaire

Patient-reported outcomes (PROs) measures will be conducted using the EORTC QLC-C30 questionnaire.

Time frame
Up to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jose Pablo Leone

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Eli Lilly and Company

Collaborator

Translational Breast Cancer Research Consortium

Collaborator

Source ClinicalTrials.gov
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