Recruiting

Personalized Second Chance

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04371913

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

600cGY x 5 fractions APBI

270cGy x 15 fractions WBRT

Study Details

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

Study ID

NCT04371913

Start date

Jun 30, 2020

Status verified date

Jan, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

600cGY x 5 fractions APBI

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

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 and Locations

Central contacts

Fabiana Gregucci

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

Locations

New York Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 10065

Contacts

Izael Nino

izn4001@med.cornell.edu

Principal Investigator:

Hani Ashamalla, M.D.

New York Presbyterian Hospital - Queens

Recruiting

New York, New York, United States, 10065

Contacts

Hina Ali, M.D

718-670-1541hia4002@med.cornell.edu

Principal Investigator:

Akkamma Ravi, M.D.

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Fabiana Gregucci, M.D.

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

Principal Investigator:

John Ng, M.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-01-27.