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

NCT04371913 | Recruiting DMC FDA Device

• 1 other identifier: 19-07020531
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of treatment related adverse events as graded by CTCAE version 5.0

  The primary endpoint of the study is to test the feasibility in terms of acute toxicity of a protocol of partial breast re-irradiation for breast cancer treatment in a previously irradiated whole breast, as defined by the rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain AEs, as graded by CTCAE version 5.0.

  up to 1 year from completion of radiation treatment

Secondary Outcomes (12)

• Number of participants with late toxicity will be measured as graded by CTCAE version 5.0

  up to 60 months

• Change in number of participants with skin changes

  baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.

• Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS)

  baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.

• Number of participants who demonstrate local control

  60 months

• Disease free survival (DFS) will be measured

  60 months

Study Arms (2)

Radiation Therapy - PBI

OTHER

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)

Radiation: 600cGY x 5 fractions APBI

Radiation Therapy - WBRT

OTHER

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)

Radiation: 270cGy x 15 fractions WBRT

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

Radiation Therapy - PBI

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)

Radiation Therapy - WBRT

Eligibility Criteria

• Age: 19 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 10065, United States

RECRUITING

New York Presbyterian Hospital - Queens

New York, New York, 10065, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Ng, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci

CONTACT

646-962-3110; fgr4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: June 30, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)