RightFit
RecruitingPhase 2

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the length of hormone-blocking treatment before surgery affects breast cancer. It is for adults age 21 or older with stage I–III breast cancer who can receive this treatment and have surgery. Researchers will study blood and tissue samples to learn how tumors respond and predict a tumor score called PEPI.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 21 or older.
  • Understand the study and sign a written consent form.
  • Have stage I–III invasive breast cancer, confirmed by a tissue or cell test. Invasive means the cancer has grown into nearby breast tissue.
  • Be able to have surgery to remove the cancer.
  • Have a recent tumor sample with more than 10% of cells testing positive for estrogen receptors, which let cells respond to estrogen.
  • Have cancer with no or low levels of a protein called HER2. If HER2 is low, you must not be a candidate for treatment that targets HER2.
  • Be able to take medicine by mouth.
  • Be willing and able to follow the visit schedule, treatment plan, and follow-up with study staff.

Who can't join

  • Cannot take the hormone-blocking treatment before surgery as directed.
  • Cannot follow the study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

DC