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
21 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
George Washington University · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer who are planning to have surgery. If you join, you will receive hormone therapy and allow researchers to take some samples from your blood and tissue to study how the treatment affects your cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with breast cancer stages I to III.
I can sign and understand the study details.
I am a candidate for surgery.
I have estrogen-positive breast cancer.
My HER2 test result is negative or low.
I can take oral medication.
I am willing to attend scheduled visits.
You may not be able to join if
I cannot comply with taking hormone therapy.
I cannot follow study procedures.
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:
1. How breast cancer responds to endocrine therapy given prior to surgery?
2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enro…
The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:
1. How breast cancer responds to endocrine therapy given prior to surgery?
2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C
Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:
* receive endocrine therapy as part of regular care for breast cancer
* consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor
* participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
* Be capable of signing and providing written consent in accordance with institutional and federal guidelines
* Histologically or cytologically confirmed diagnosis of inv…
Inclusion Criteria:
* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
* Be capable of signing and providing written consent in accordance with institutional and federal guidelines
* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
* Clinical stage 1 to 3 breast cancer
* Candidate for surgical resection
* Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
* Ability to take oral medication
* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
* Age ≥ 21 years
Exclusion Criteria:
* Inability to comply taking NET
* Inability to comply to study procedures
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