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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: 600cGY x 5 fractions APBI; Radiation: 270cGy x 15 fractions WBRT

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.

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.

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 or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received.

The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Enrollment: 120 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
• 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

• Regional recurrences (axillary, supraclavicular)
• Positive histologic margins at resection
• Metastatic disease
• Poor cosmesis from previous surgery and RT
• Extensive Intraductal Component

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Radiation Therapy - PBI

Other group

Description:

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)

Treatment:

Radiation: 600cGY x 5 fractions APBI

Radiation Therapy - WBRT

Other group

Description:

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)

Treatment:

Radiation: 270cGy x 15 fractions WBRT