Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
NCT ID: NCT04371913
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2020-06-30
2035-12-31
Brief Summary
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An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.
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Detailed Description
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The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiation Therapy - PBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated partial breast irradiation (PBI) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
600cGY x 5 fractions APBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT
Radiation Therapy - WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
270cGy x 15 fractions WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
Interventions
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600cGY x 5 fractions APBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT
270cGy x 15 fractions WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
Eligibility Criteria
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Inclusion Criteria
* Limited size (\< 2-3 cm) without evidence of skin involvement
* Histologically proven invasive breast carcinoma or carcinoma in situ
* Negative histologic margins of resection
* Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
* No synchronous distant metastases
* Age ≥ 18 years
* ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
* Previous WBI or IORT, brachytherapy or external beam partial breast treatment
* Technical feasibility
* Every kind of systemic therapy is allowed
* Informed consent for clinical and research purposes signed
Exclusion Criteria
* Positive histologic margins at resection
* Metastatic disease
* Poor cosmesis from previous surgery and RT
* Extensive Intraductal Component
19 Years
90 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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John Ng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
New York Presbyterian Hospital - Queens
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-07020531
Identifier Type: -
Identifier Source: org_study_id
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