Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant endocrine therapy, Neoadjuvant endocrine therapy, Neoadjuvant endocrine therapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Carcinoma, Breast. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Neoadjuvant endocrine therapy
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks) - Drug Neoadjuvant endocrine therapy
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks - Drug Neoadjuvant endocrine therapy
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Primary outcome measures
- Response to neoadjuvant endocrine therapy (NET) [Time frame: From enrollment to the end of treatment at <=52 weeks]
Secondary outcome measures (2)
- Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C [Time frame: From enrollment to the end of treatment at <=52 weeks]
- Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells). [Time frame: From enrollment to the end of treatment at <=52 weeks]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- George Washington-Medical Faculty Associates — Washington D.C.
Identifiers
NCT: NCT06806930 · Neo-PREDICT