RECRUITING

DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)

Official Title

A Randomized, Phase II Trial of Circulating Tumor DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

Quick Facts

Study Start:2021-02-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04567420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Felicitas Ambrose
CONTACT
5185830095
fambrose@criteriuminc.com
Julee Hartwell
CONTACT
607-651-6273
jhartwell@criteriuminc.com

Principal Investigator

Lajos Pusztai, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
Louisiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, 70112
United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Stony Brook University Cancer Center
Stony Brook, New York, 11794
United States
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, 43210
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Criterium, Inc.

  • Lajos Pusztai, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-02-09
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • ctDNA
  • breast cancer
  • high residual risk

Additional Relevant MeSH Terms

  • Breast Cancer