Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04371913
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 600cGY x 5 fractions APBI — RADIATION
    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 — RADIATION
    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)

Study Details

The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins. 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.

Key Dates

Start date
Jun 30, 2020
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: 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)
  • Other: 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)

Primary Outcome Measure

Rate of treatment related adverse events as graded by CTCAE version 5.0 [ Time Frame: up to 1 year from completion of radiation treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
New York Presbyterian Brooklyn Methodist HospitalBrooklynNew York10065
Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - QueensNew YorkNew York10065
Hina Ali, M.D
[email protected]
718-670-1541
Akkamma Ravi, M.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Fabiana Gregucci, M.D.
[email protected]
646-962-3110
John Ng, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Brooklyn, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
New York Presbyterian Brooklyn Methodist Hospital· Brooklyn, NYNew York Presbyterian Hospital - Queens· New York, NYWeill Cornell Medicine· New York, NY

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