Recruiting

Radiation Registry

Sponsor:

Albert Einstein College of Medicine

Code:

NCT04994067

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.

Conditions

Breast Cancer

Study ID

NCT04994067

Start date

Aug 9, 2018

Status verified date

Sep, 2025

Completion date

Aug, 2032

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female gender
  • Age ≥ 45
  • cT1-2N0, <3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, < 2.5 cm, estrogen-receptor positive
  • Suitable for breast conserving surgery
  • No contraindication to radiation
  • Mammogram within 6 months of planned procedure
  • Fitness for lumpectomy under general anesthesia
  • Planned to receive IORT

Exclusion criteria

  • Known axillary lymph node positive breast cancer (negative biopsy not required)
  • Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
  • Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
  • Patients undergoing neoadjuvant chemotherapy
  • Pregnancy

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of patients with locally controlled disease [ Time Frame: 5 years following radiation therapy ]
  • Number of patients with regionally controlled disease [ Time Frame: 5 years following radiation therapy ]
  • Number of patients with grade 2 or higher toxicities [ Time Frame: 5 years following radiation therapy ]

Central Contacts and Locations

Central contacts

Jana Fox, MD

718-920-4140jfox@montefiore.org

Locations

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467-2490

Contacts

Jana Fox

718-920-4140jfox@montefiore.org

Principal Investigator:

Jana Fox

More Information

Sponsor

Albert Einstein College of Medicine

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • intraoperative radiation therapy
  • partial breast irradiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albert Einstein College of Medicine on 2025-09-23.