Definitive Radiation Therapy for Inoperable Breast Cancer

NCT07122713 | Recruiting DMC FDA Device

• 2 other identifiers: SBU-BREAST-DEFINEIRB2024-00364
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment Safety

  Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0

  12 months

Secondary Outcomes (7)

• Acute Toxicity

  12 months

• Late Toxicity

  5 years

• Treatment Tolerability by EORTC QLQ-C30

  2 years

• Treatment Tolerability by EORTC QLQ-BR42

  2 years

• Tumor Response Rate in the Gross Disease Volume (40Gy)

  1 year

Study Arms (2)

A: Ipsilateral axillary node-negative breast cancer

EXPERIMENTAL

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

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

B: Ipsilateral axillary node-positive breast cancer

EXPERIMENTAL

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

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

Interventions

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

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

A: Ipsilateral axillary node-negative breast cancer

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

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

B: Ipsilateral axillary node-positive breast cancer

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexander Stessin: lead
• Northwell Health: collaborator

Study Sites (1)

Stony Brook University Cancer Center

Stony Brook, New York, 11794, 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

• Alexander Stessin, MD PhD

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caterina Stony Brook Cancer Center Clinical Trials

CONTACT

631-728-7425; cancerclinicaltrials@sronybrookmedicine.edu

Caterina Vacchi-Suzzi, PhD

CONTACT

6312162993; caterina.vacchi-suzzi@stonybrookmedicine.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 INVESTIGATOR
• PI Title: Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 14, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2033
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)