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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

StatusRecruiting
PhasePhase 2
Started2024-02-17
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 36 times since 2023-10-04; most recent filed 2026-07-17. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-07-17
Amendment Study Status, Eligibility v36
2026-05-19
Amendment Study Status, Contacts/Locations v35
2026-05-07
Amendment Study Status, Eligibility, Contacts/Locations v34
2026-04-28
Amendment Study Status, Contacts/Locations v33
2026-04-21
Amendment Study Status, Contacts/Locations v32
2026-03-12
Amendment Study Status, Contacts/Locations v31
2026-03-10
Amendment Study Status, Contacts/Locations v30
2026-01-16
Amendment Study Status, Contacts/Locations v29
2025-12-12
Amendment Study Status, Contacts/Locations v28
2025-11-19
Amendment Study Status, Contacts/Locations v27
2025-11-03
Amendment Study Status, Contacts/Locations v26
2025-10-22
Amendment Study Status, Oversight, Contacts/Locations v25
2025-10-17
Amendment Study Status, Contacts/Locations v24
2025-10-01
Amendment Study Status, Contacts/Locations v23
2025-09-04
Amendment Study Status, Contacts/Locations v22
2025-08-25
Amendment Study Status, Contacts/Locations v21
2025-08-12
Amendment Study Status, Contacts/Locations v20
2025-07-28
Amendment Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v19
2025-07-21
Amendment Study Status, Contacts/Locations v18
2025-06-24
Amendment Study Status, Contacts/Locations v17
2025-06-13
Amendment Study Status, Contacts/Locations v16
2025-06-04
Amendment Study Status, Contacts/Locations v15
2025-05-27
Amendment Study Status, Contacts/Locations v14
2025-04-27
Amendment Study Status, Oversight, Contacts/Locations v13
2024-10-06
Amendment Study Status, Contacts/Locations v12
2024-09-04
Amendment Study Status, Contacts/Locations v11
2024-06-26
Amendment Study Status, Contacts/Locations v10
2024-06-17
Amendment Study Status v9
2024-06-17
Amendment Study Status, Contacts/Locations v8
2024-03-25
Amendment Study Status, Contacts/Locations v7
2024-01-30
Amendment Study Status, Contacts/Locations v6
2024-01-22
Amendment Study Status, Study Description, Arms and Interventions, Contacts/Locations v5
2024-01-11
Amendment Study Status, Contacts/Locations v4
2023-11-22
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v3
2023-11-01
Amendment Study Status, Study Design, Arms and Interventions v2
2023-10-13
Amendment Study Status, Arms and Interventions v1
2023-10-04
Original filing
Trial Details
NCT Number NCT06075953
Lead Sponsor QuantumLeap Healthcare Collaborative
Conditions Ductal Carcinoma in Situ
Enrollment 400 participants
Start Date 2024-02-17
Primary Completion 2028-11 (estimated)
Study Completion 2033-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-21