DARE Study: DNA-Guided Therapy for High-Risk Breast Cancer
This study, called DARE, is for people with high-risk, estrogen receptor-positive (meaning the cancer cells have receptors for the hormone estrogen), HER2-negative breast cancer. It's looking at how well a DNA-guided approach works for second-line adjuvant therapy (treatment given after initial therapy to prevent recurrence). The study will use Palbociclib and Fulvestrant, which are drugs that target specific mechanisms in cancer cells (CDK and CDK4). You might be eligible if you have this type of breast cancer and are at high risk for it coming back. The study aims to see how effective this DNA-guided treatment is over an average of six years. The current status of this study is unclear, and it plans to enroll 70 participants.
- Study design
- This is a randomized, Phase II interventional study. It aims to enroll 70 participants.
- What's involved
- You would undergo Signatera testing (a type of blood test) during routine follow-up clinic visits. The study involves 4-week cycles of Palbociclib and Fulvestrant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be measured through study completion, which is an average of 6 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
At a glance
Conditions
Where it's being run
19 sites across 16 statesStudy leadership
- Lajos Pusztai, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Surveillance/ctDNA screening Phaseenrollment
Primary objective of the ctDNA screening (surveillance) phase is to assess the incidence of ctDNA detection (i.e. ctDNA positivity) in patients with ER positive HER2- breast cancer who are receiving standard of care adjuvant endocrine therapy but remain high risk for recurrence.
- Therapeutic Phasethrough study completion, an average of 6 years
Primary objective of the therapeutic randomized phase is to assess whether palbociclib plus fulvestrant improves relapse free survival compared to standard endocrine therapy in patients with ER positive HER2 negative breast cancer with detectable circulating tumor DNA during adjuvant endocrine therapy without clinical evidence of metastatic disease.