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: Lajos Pusztai, MD, of Yale Cancer Center 

Description: Researchers are conducting a phase 2 trial to determine if circulating tumor DNA (ctDNA) testing can guide second-line adjuvant therapy in patients with high-risk, stage II-III, estrogen receptor (ER)-positive, HER2-negative breast cancer.


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The study will enroll patients who are currently receiving adjuvant endocrine therapy and have a high risk of disease recurrence. 

The study is split into a surveillance phase and a therapeutic phase. During the surveillance phase, patients will undergo ctDNA screening. The primary objective for this phase is to assess ctDNA positivity in patients receiving standard adjuvant endocrine therapy who remain at high risk of recurrence.

During the therapeutic phase, patients will be randomly assigned to receive palbociclib plus fulvestrant or to remain on standard therapy. The primary objective in this phase is to determine whether palbociclib plus fulvestrant improves relapse-free survival compared with standard therapy in patients who have detectable ctDNA in the plasma but no evidence of metastatic disease on imaging. 

Secondary outcome measures include the correlation between clinically apparent metastatic or local disease and a positive ctDNA result, the ability of a ctDNA result to predict relapse, and adverse events.

To be eligible for this study, patients must have stage II or III, HER2-negative, ER-positive invasive breast cancer. 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 June 22, 2022.