Actively Recruiting
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
Led by Criterium, Inc. · Updated on 2025-10-16
70
Participants Needed
19
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High risk for recurrence HER-2 negative, estrogen receptor positive invasive breast cancer with ER positivity ≥10% by immunohistochemistry
- Completed adjuvant endocrine therapy or currently taking aromatase inhibitor or tamoxifen with at least 6 months but no more than 7 years of therapy
- Prior adjuvant CDK4/6 therapy allowed if last treatment was 12 or more months ago
- High recurrence risk defined by ≥4 involved ipsilateral axillary lymph nodes or positive supraclavicular, infraclavicular, or internal mammary lymph nodes; or tumor size >5 cm with at least one positive lymph node; or diagnosis of inflammatory breast cancer
- Formalin fixed paraffin embedded tissue available for ctDNA testing
- Signed informed consent including willingness to be randomized
You will not qualify if you...
- Prior or current treatment with fulvestrant or CDK4/6 inhibitor within the last 12 months
- Participation in another therapeutic breast cancer trial during this study unless disease progression or withdrawal occurred
- Current or past invasive cancers other than breast cancer, except adequately treated skin basal or squamous cell carcinoma or other invasive cancers with no recurrence for 5 years and low risk
- Presence of second HER2 positive or triple negative synchronous breast cancer
- Known contraindications or intolerance to fulvestrant or palbociclib
- Severe uncontrolled medical conditions including gastrointestinal diseases affecting drug absorption, history of pneumonitis or lung disease, HIV, active hepatitis B or C
- Pregnant or breastfeeding females
- History of bleeding disorders preventing injections
- Use of strong CYP3A4 inducers or inhibitors that cannot be changed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Completed
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Intermountain
Golden, Colorado, United States, 80401
Actively Recruiting
6
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Louisiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
9
Cancer Partners of Nebraska
Lincoln, Nebraska, United States, 68516
Actively Recruiting
10
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
12
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
13
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
15
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
16
PRiSMs Group
Laredo, Texas, United States, 78041
Actively Recruiting
17
Virginia Cancer Institute
Richmond, Virginia, United States, 23229
Actively Recruiting
18
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
19
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
B
Bebi Yassin-Rajkumar, MSc
CONTACT
J
Julee Hartwell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here