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

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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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