DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Criterium, Inc.
- Study ID
- NCT04567420
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Palbociclib — DRUG4 week cycles
- Fulvestrant — DRUG4 week cycles
- Adjuvant Therapy — DRUGStandard of Care
Study Details
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)
Key Dates
- Start date
- Feb 9, 2021
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm APalbociclib/Fulvestrant Combination
- Active Comparator: Arm BAdjuvant Therapy
Primary Outcome Measure
Surveillance/ctDNA screening Phase [ Time Frame: enrollment ]
Central Contacts
- Bebi Yassin-Rajkumar, MSc6138511370
- Julee Hartwell607-651-6273
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | Sima Ehsani, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | - |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Evanthia Torres, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | Peter Kabos, MD (PRINCIPAL_INVESTIGATOR) |
| Intermountain | Golden | Colorado | 80401 | Karng Log (PRINCIPAL_INVESTIGATOR) |
| Yale Cancer Center | New Haven | Connecticut | 06510 | Carl Brown Lajos Pusztai, MD (PRINCIPAL_INVESTIGATOR) |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Manali Bhave, MD (PRINCIPAL_INVESTIGATOR) |
| Louisiana State University Health Sciences Center- New Orleans | New Orleans | Louisiana | 70112 | Michelle Loch, MD (PRINCIPAL_INVESTIGATOR) |
| Cancer Partners of Nebraska | Lincoln | Nebraska | 68516 | Sheila Evans Joni Tilford (PRINCIPAL_INVESTIGATOR) |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87131 | Ellen R Wojcik Bernard Tawfik, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Paula Klein, MD (PRINCIPAL_INVESTIGATOR) |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794 | Alison Stopeck, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University Wexner Medical Center James Cancer Hospital | Columbus | Ohio | 43210 | Sagar Sardesai, MD (PRINCIPAL_INVESTIGATOR) |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Wajeeha Razaq, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health and Science University | Portland | Oregon | 97239 | Jeanette Phillips 971-262-9041 Alexandra Zimmer, MD (PRINCIPAL_INVESTIGATOR) |
| PRiSMs Group | Laredo | Texas | 78041 | Ekta Grewal Eduardo Miranda (PRINCIPAL_INVESTIGATOR) |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | Stacey Wright Sharon Goble (PRINCIPAL_INVESTIGATOR) |
| Swedish Cancer Institute | Seattle | Washington | 98104 | Danielle M File, MD (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | Marina Sharifi, MD (PRINCIPAL_INVESTIGATOR) |
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