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NCT06075953 · ClinicalTrials.gov registry record · Phase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
A Phase 2 study of Ductal Carcinoma In Situ, sponsored by QuantumLeap Healthcare Collaborative.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06075953 is a Phase 2 study of Ductal Carcinoma In Situ that is actively recruiting participants, run by QuantumLeap Healthcare Collaborative. The registered enrollment target is 400 participants, above the 231-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT06075953, a Phase 2 study of Ductal Carcinoma In Situ, is actively recruiting participants, sponsored by QuantumLeap Healthcare Collaborative.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Letrozole
- DRUG Exemestane
- DRUG Anastrazole
- DRUG Testosterone + Anastrazole
Study Locations (20)
California
- Berkeley Outpatient Center - Berkeley
- City of Hope -Duarte Cancer Center - Duarte
- City of Hope - Lennar Foundation Cancer Center - Irvine
- UCLA - Los Angeles
- UCSF - San Francisco
- City of Hope - South Pasadena
- John Muir Health - Walnut Creek
Minnesota
- Maple Grove Cancer Center - Maple Grove
- Hennepin Healthcare -Minneapolis - Minneapolis
- University of Minnesota - Minneapolis
- Health Partners - Frauenshuh Cancer Center - Saint Louis Park
- Health Partners - Regions Hospital - Saint Paul
New York
- Mount Sinai Union Square - New York
- Mount Sinai Chelsea - New York
- Mount Sinai West - New York
- Icahn School of Medicine at Mount Sinai - New York
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
New Jersey
- Englewood Hospital and Medical Center - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-02-17 |
| Est. Completion | 2033-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06075953
The ClinicalTrials.gov registry entry for NCT06075953 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 231-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (73% higher). The listed sponsor is QuantumLeap Healthcare Collaborative, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ductal Carcinoma In Situ appearing as the primary indexed condition, and to 5 interventions - of which Tamoxifen is the first listed.
NCT06075953 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT06075953 about?
NCT06075953 is a clinical study titled "DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment". The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or ...
What is the current status of trial NCT06075953?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2024-02-17. Estimated completion is 2033-11.
What conditions does trial NCT06075953 study?
This clinical trial studies the following conditions: Ductal Carcinoma In Situ.
What interventions are being tested in trial NCT06075953?
The interventions under investigation include: Tamoxifen (DRUG), Letrozole (DRUG), Exemestane (DRUG), Anastrazole (DRUG), Testosterone + Anastrazole (DRUG).
Who is sponsoring clinical trial NCT06075953?
This trial is sponsored by QuantumLeap Healthcare Collaborative, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06075953 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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