Title: A randomized phase II trial of circulating tumor DNA-guided second line adjuvant therapy for high residual risk, stage II-III, hormone receptor positive, HER2 negative breast cancer

Principal Investigator: Lazos Pusztai, MD, of Yale University in New Haven, Connecticut

Description: Researchers are conducting a phase 2 trial to determine if circulating tumor DNA (ctDNA) can be used to guide treatment in patients with estrogen receptor (ER)-positive, HER2-negative breast cancer at high risk of recurrence.


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The study is enrolling patients with stage II-III, ER-positive, HER2-negative breast cancer who are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen. Patients must meet 1 of 5 criteria suggesting they have a high risk of recurrence.

The patients will undergo ctDNA screening during routine follow-up clinic visits. The primary objective of the trial’s screening phase is to determine the incidence of ctDNA positivity in these patients.

In the therapeutic phase of the trial, patients with detectable ctDNA in the plasma but without evidence of metastatic disease on imaging will be randomly assigned to continue on standard adjuvant endocrine therapy or to receive palbociclib plus fulvestrant. The primary objective of the therapeutic phase is to determine whether palbociclib plus fulvestrant can improve relapse-free survival vs standard care.

Secondary objectives of this trial include the feasibility of ctDNA surveillance, the ability of positive ctDNA results to predict clinical relapse, and the safety and tolerability of the treatments.

To be eligible for this study, patients must have stage II or III, ER-positive, HER2-negative invasive breast cancer and a high risk of recurrence. Patients must have completed at least 6 months, but no more than 7 years, of endocrine therapy without recurrence. For a complete list of eligibility criteria, please see the reference. 

Status: Recruiting

This study is sponsored by Criterium, Inc.

Reference

ClinicalTrials.gov. DNA-guided second line adjuvant therapy for high residual risk, stage II-III, hormone receptor positive, HER2 negative breast cancer (DARE). NCT04567420. Accessed November 21, 2022.