Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
Part of paid clinical trials in Norwalk, Connecticut.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT04084730
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Breast Cancer
- DCIS
- DCIS Grade 1
- DCIS Grade 2
- Invasive Ductal Breast Carcinoma
- Invasive Ductal Carcinoma, Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 45 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Accelerated Partial Breast Irradiation — RADIATIONTreatment will consist of APBI delivered using external beam RT techniques to a dose of 24 Gy in 3 fractions of 8.0 Gy delivered on consecutive weekdays
Study Details
The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.
Key Dates
- Start date
- Aug 30, 2019
- Status verified
- Sep 2025
- Primary completion
- Aug 30, 2026
- Completion
- Aug 30, 2026
Study Design
- Enrollment
- 280 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with Breast CancerParticipants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring \<3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.
Primary Outcome Measure
Toxicity with novel APBI schedule as determined by CTCAE version 5 [ Time Frame: 24 months ]
Central Contacts
- Atif J Khan, MD848-225-6334
- Simon Powell, MD, PhD212-639-3639
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Norwalk Hospital | Norwalk | Connecticut | 06850 | Philip Gilbo, MD 203-845-4811 |
| Baptist Alliance Miami Cancer Institute | Miami | Florida | 33143 | Joseph Panoff, MD 786-596-2000 |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | Atif J Khan, MD 848-225-6334 |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | Atif J Khan, MD 848-225-6334 |
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