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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 years

Awards & highlights

DARE Trial 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.Check my eligibility

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.See study design

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.

DARE Trial 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.

DARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surveillance/ctDNA screening Phase

Therapeutic Phase

Secondary outcome measures

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

DARE 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

~3760

Fulvestrant

2011

Completed Phase 3

~3690

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Criterium, Inc.Lead Sponsor

16 Previous Clinical Trials

674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Palbociclib?

"On a scale of 1 to 3, Palbociclib's safety was evaluated as 2 due to pre-existing preliminary clinical data indicating its hazards but with no evidence yet in terms of efficacy."

Answered by AI

Is recruitment still open for participants of this experiment?

"According to the details posted on clinicaltrials.gov, this medical study is still looking for participants and was initially listed on February 9th 2021 with its last update occurring in August 2022."

Answered by AI

What is the cohort size for this research experiment?

"To complete this medical trial, 100 qualified candidates must be found. Such individuals can apply to the study from Icahn School of Medicine at Mount Sinai in New york, Louisiana and Louisiana State University Health Sciences Center- New Orleans in New Orleans, or other locations throughout New mexico."

Answered by AI

What therapeutic applications are associated with Palbociclib?

"Palbociclib is typically prescribed to combat malignant neoplasms, though it has also been employed in the treatment of conditions like pik3ca gene mutation, progression and disease alongside prior endocrine therapy."

Answered by AI

What precedent has been set with regards to the use of Palbociclib in clinical research?

"There are currently 236 ongoing studies involving palbociclib, with 42 being at the late-stage Phase 3 level. Most experiments take place in Burgas, New jersey; however, there exists an extensive network of 10932 clinical trial sites studying this medication."

Answered by AI

In what geographic areas are the trials of this protocol being conducted?

"Patients are able to join this trial at Icahn School of Medicine at Mount Sinai in New york, Louisiana State University Health Sciences Center- New Orleans in New Orleans, and the New mexico Cancer Care Alliance in Albuquerque. Plus, there are 13 other sites across various states that have been approved for enrollment."

Answered by AI

What is the ultimate goal of this study?

"As reported by Criterium, Inc., the chief metric to measure over this trial period is Therapeutic Phase. Additionally, secondary objectives such as assessing correlation of ctDNA clearance with relapse free survival and overall survival in both treatment arms will be evaluated, along with estimating the proportion of patients who have imaging-positive metastatic or local disease at first positive ctDNA result."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer

2021. "DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04567420.

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