Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorGeorge Washington University
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Inability to comply taking NET
Inability to comply to study procedures
Trial design
Treatments tested in this trial
- Neoadjuvant endocrine therapy
- Neoadjuvant endocrine therapy
- Neoadjuvant endocrine therapy
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov