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

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Weill Cornell Medicine (WCM)

Status and phase

Enrolling
Phase 2

Conditions

Breast Cancer

Treatments

Radiation: 600cGY x 5 fractions

Study type

Interventional

Funder types

Other

Identifiers

NCT04371913
19-07020531

Details and patient eligibility

About

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.

Full description

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 Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT. The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Enrollment

60 estimated patients

Sex

Female

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Isolated ipsilateral unifocal breast lesions
  • 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
  • Technical feasibility
  • Every kind of systemic therapy is allowed
  • Informed consent for clinical and research purposes signed

Exclusion criteria

  • Regional recurrences (axillary, supraclavicular)
  • Positive histologic margins at resection
  • Metastatic disease
  • Poor cosmesis from previous surgery and RT
  • Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
  • Extensive Intraductal Component

Trial design

60 participants in 1 patient group

Radiation Therapy
Other group
Description:
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 External Beam Radiation Therapy (EBRT).
Treatment:
Radiation: 600cGY x 5 fractions

Trial contacts and locations

0

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Central trial contact

Lhaden Tshering

Data sourced from clinicaltrials.gov

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