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DNA-Guided Adjuvant Therapy for Breast Cancer (DARE Trial)

Phase 2
Recruiting
Led By Lajos Pusztai, MD
Research Sponsored by Criterium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with stage II or III, HER2 negative, ER positive invasive breast cancer in male or female patients, with ER positivity defined as equal to or greater than 10% ER positivity by immunohistochemistry, regardless of progesterone receptor (PR) status. Patients with PR positive but ER negative cancer are not eligible. HER2 negative status is defined as per the ASCO/CAP 2018 practice guidelines.
No evidence of metastatic disease on CT scan of the chest, abdomen and pelvis.
Must not have
Patients taking any CYPC3A4 strong inducers and inhibitors, that cannot be changed.
Patients with a second HER2 positive or triple negative synchronous breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to choose second-line adjuvant therapy for a certain type of breast cancer.

Who is the study for?
This trial is for men and women with stage II-III, HER2 negative, ER positive breast cancer who have been on hormone therapy for 6 months to 7 years. They must not show signs of cancer spread and agree to use contraception. Those with high recurrence risk or ctDNA positivity are eligible. Exclusions include intolerance to the drugs being tested, severe health issues, living outside the US, certain cancer histories, or taking specific medications.
What is being tested?
The DARE trial tests if adding Palbociclib and Fulvestrant (second line adjuvant therapies) can benefit patients with a high residual risk of breast cancer after initial treatment. It's randomized: some will get standard care while others receive the new combination; decisions are made by chance.
What are the potential side effects?
Palbociclib may cause low white blood cell counts leading to infection risk, fatigue, nausea, hair thinning and mouth sores. Fulvestrant can result in injection site pain, nausea and liver enzyme changes. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is stage II or III, HER2 negative, and ER positive.
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My scans show no cancer spread to other parts of my body.
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My cancer is at high risk of coming back based on its size, spread to lymph nodes, type, and genetic risk.
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I can provide a tissue sample from my original tumor for testing.
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My blood test shows cancer markers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on medication that strongly affects liver enzyme levels and cannot switch.
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I have a second breast cancer that is either HER2 positive or triple negative.
Select...
I cannot take fulvestrant and palbociclib due to adverse reactions or other reasons.
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I have a history of cancer.
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I have had a condition where my lymphocytes grow abnormally.
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I will not join another breast cancer treatment trial after this one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surveillance/ctDNA screening Phase
Therapeutic Phase
Secondary study objectives
Secondary Objective 1: Feasibility- correlation between clinically apparent metastatic or local disease and positive ctDNA result.
Secondary Objective 2: Efficacy- assess the ability of positive ctDNA results to predict clinical relapse.
Secondary Objective 3: Efficacy- assess whether ctDNA clearance is associated with improved relapse free survival and overall survival.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
Palbociclib/Fulvestrant Combination
Group II: Arm BActive Control1 Intervention
Adjuvant Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3790
Fulvestrant
2011
Completed Phase 3
~3790

Find a Location

Who is running the clinical trial?

Criterium, Inc.Lead Sponsor
17 Previous Clinical Trials
692 Total Patients Enrolled
3 Trials studying Breast Cancer
116 Patients Enrolled for Breast Cancer
Lajos Pusztai, MDPrincipal InvestigatorYale University
3 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Breast Cancer
290 Patients Enrolled for Breast Cancer

Media Library

Palbociclib Clinical Trial Eligibility Overview. Trial Name: NCT04567420 — Phase 2
Breast Cancer Research Study Groups: Arm A, Arm B
Breast Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT04567420 — Phase 2
Palbociclib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567420 — Phase 2
~21 spots leftby Dec 2025
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