Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

George Washington University (GW)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer Stage II; Breast Cancer Stage I; Carcinoma, Breast; Breast Cancer Stage III

Treatments: Drug: Neoadjuvant endocrine therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06806930

Neo-PREDICT

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Cohort A: Short Duration NET

Active Comparator group

Description:

Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)

Treatment:

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy

Cohort B: Intermediate Duration NET

Active Comparator group

Description:

Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks

Treatment:

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy

Cohort C: Extended Duration NET

Active Comparator group

Description:

Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks

Treatment:

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy

Drug: Neoadjuvant endocrine therapy