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Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

StatusRecruiting
PhasePhase 2
Started2019-08-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 30, 2026 → Aug 30, 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-22
Primary completion pushed: 2026-08-30 → 2027-08-30
Completion pushed: 2026-08-30 → 2027-08-30
2025-09-15
Study Status v20
Primary completion date2025-08-30→2026-08-30
Completion date2025-08-30→2026-08-30
2025-07-07
Study Status v19
Re-verified, no change to tracked fields
2025-04-23
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v18
Eligibility criteriarevised
[...] mediate risk substudy: Post-NAC cohort patients: clinical T1 or -T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT [...]
Study sitescontacts updated at 1 of 9 sites
Study titlerevised
Study of 3-Day Partial Breast Radiation Therapy in Women withWith Breast Cancer
2025-02-13
Study Identification, Study Status, Oversight, Contacts/Locations v17
Study sitescontacts updated at 1 of 9 sites
Study titlerevised
Study of 3-Day Partial Breast Radiation Therapy in Women Withwith Breast Cancer
Show 16 earlier versions
2025-01-17
Study Status v16
Re-verified, no change to tracked fields
2024-09-30
Study Status v15
Primary completion date2024-08-30→2025-08-30
Completion date2024-08-30→2025-08-30
2024-07-10
Study Status, Eligibility v14
Eligibility criteriarevised
[...] try or hematoxylin and eosin staining) will also be eligible. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is <=2 cm and hormone-receptor positive, are also eligible. Histologically negative tumor margin or no tumor in a re-exc [...] n final shaved specimen. ECOG Performance Status of 0 or 1. Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery. Negative serum pregnancy test within 14 days prior to stu [...]
2024-05-22
Study Status, Study Design v13
Enrollment target400→280
2023-06-14
Study Status, Eligibility v12
Eligibility criteria+18 characters
[...] ng) and clinical N0 (on exam and imaging) with pathological pT0ypT0, ypTis, or pTisypT1 (<=2cm) and pN0ypN0 (any regimen of neoadjuvant chemotherapy agents is allowed) [...]
2023-02-22
Study Status, Study Design, Eligibility v11
Primary completion date2023-08-30→2024-08-30
Completion date2023-08-30→2024-08-30
Enrollment target140→400
Eligibility criteria-166 characters
[...] in first degree relatives) OR Invasive lobular carcinoma OR WomenSurgical 70margins less than 1 mm to invasive or olderin-situ with tumors 2.0 cm or less in size and with clinically or pathologically negative nodes who decline or are ineligible for hormonal therapy OR discontinue hormonal therapy within 3 months of initiating treatmentdisease. Exclusion Criteria: Patients with distant metastasis Patie [...]
2022-10-04
Study Status, Contacts/Locations v10
Study sites9 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge MemoralMemorial Sloan Kettering Monmouth MemoralMemorial Sloan Kettering Westchester
2022-08-25
2 amendments v8-v9
2 re-verifications since 2022-03-21, no change to tracked fields
2021-07-16
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 9 sites
2021-05-26
Study Status v6
Re-verified, no change to tracked fields
2021-03-10
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 9 sites
2021-02-11
Study Status, Eligibility, Contacts/Locations v4
Primary completion date2022-08-30→2023-08-30
Completion date2022-08-30→2023-08-30
Study sites8→9
Eligibility criteria+282 characters
[...] stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or Grade 1 or 2 (low or intermediate grade) DCIS measuring <3 cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC. If T2, the tumor must be less than 3cm in longest diameter. Note: Women >≥ 70 years or older with T1 invasive ductal carcinoma who are [...] er in first degree relatives) OR Invasive lobular carcinoma OR Women 70 or older with tumors 2.0 cm or less in size and with clinically or pathologically negative nodes who decline or are ineligible for hormonal therapy OR discontinue hormonal therap [...] [...]
2020-10-13
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 8 sites
2020-09-08
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 8 sites
2020-06-24
Study Status, Eligibility, Contacts/Locations v1
Study sites7→8
Eligibility criteria+444 characters
[...] ed or "not otherwise specified") in the lumpectomy specimen OR Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family history of breast cancer in first degree relatives) OR Invasive lobular carcinoma Exclusion Criteria: Patients with distant metastasis Patient [...] or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and/or appear multifocal due to sectioning is allowed after review [...] [...]
2019-09-09
Original filing
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.
Trial Details
NCT Number NCT04084730
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Invasive Ductal Breast Carcinoma, Invasive Ductal Carcinoma, Breast, DCIS, DCIS Grade 1, DCIS Grade 2, Breast Cancer
Enrollment 280 participants
Start Date 2019-08-30
Primary Completion 2027-08-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21