Recruiting

Radiation Therapy

Sponsor:

Alexander Stessin

Code:

NCT07122713

Conditions

Breast Cancer

Breast Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor

Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes

Study Details

Brief summary:

The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.

Conditions

Breast Cancer

Breast Adenocarcinoma

Study ID

NCT07122713

Start date

Dec 8, 2025

Status verified date

Dec, 2025

Completion date

Dec 30, 2033

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
  • T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
  • Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
  • Life expectancy > 6 months
  • Negative pregnancy test at the time of start of treatment in any female of reproductive age

Exclusion Criteria:

  • Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
  • Prior radiation to ipsilateral breast or regional nodes
  • Inability to receive study treatment planning and treatment secondary to body habitus

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A: Ipsilateral axillary node-negative breast cancer

Patients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1)

experimental: B: Ipsilateral axillary node-positive breast cancer

Patients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1)

Interventions

Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor

Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions

Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes

Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions

Primary outcome measure

  • Treatment Safety [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Caterina Stony Brook Cancer Center Clinical Trials

631-728-7425cancerclinicaltrials@sronybrookmedicine.edu

Caterina Vacchi-Suzzi, PhD

6312162993caterina.vacchi-suzzi@stonybrookmedicine.edu

Locations

Stony Brook University Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Cancer Clinical Trials Office

(631)-728-7425CancerClinicalTrials@stonybrookmedicine.edu

cancerclinicaltrials@stonybrookmedicine.edu

Principal Investigator:

Alexander Stessin, MD PhD

More Information

Sponsor

Alexander Stessin

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • inoperable breast cancer
  • radiation therapy
  • breast radiation
  • novel treatment
  • new treatment breast
  • cyberknife
  • non-invasive
  • stereotactic radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexander Stessin on 2025-12-17.