Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07122713

Definitive Radiation Therapy for Inoperable Breast Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Alexander Stessin, MD PhD

PRINCIPAL_INVESTIGATOR

Cancer Clinical Trials Office

CONTACT

[email protected]

(631)-728-7425

CONTACT

[email protected]

About this study

Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Treatment Safety

    Time frame: 12 months

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

Secondary outcomes

  1. Acute Toxicity

    Time frame: 12 months

    Percent of participants with any physician-assessed treatment-related Grade 1-5 events using CTCAE 5.0. Grade 1 events are limited to fatigue, skin, breast, ribs, heart and lungs.

  2. Late Toxicity

    Time frame: 5 years

    Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.

  3. Treatment Tolerability by EORTC QLQ-C30

    Time frame: 2 years

    Patient reported quality of life measured using the quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms.

  4. Treatment Tolerability by EORTC QLQ-BR42

    Time frame: 2 years

    Patient reported quality of life measured using the quality of life questionnaire BR42 (QLQ-BR42), developed by the European Organisation for Research and Treatment of Cancer. This scale assesses symptoms, body image and sexual functioning scales, each scored as a 0-100 scale, where higher scores indicate worse outcome on symptoms.

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

    Time frame: 1 year

    Measured on follow-up MRI or CT imaging using RECIST criteria

  6. Progression Free Rate in the Microscopic Disease Volume (26Gy)

    Time frame: 1 year

    Measured on follow-up MRI or CT imaging using RECIST criteria

  7. Clinical Response in patients with Palpable Disease

    Time frame: 1 year

    Caliper measurements (2-dimensional)

Study contacts

Contact information is provided by the study sponsor or research team.

Caterina Stony Brook Cancer Center Clinical Trials

CONTACT

[email protected]

631-728-7425

Caterina Vacchi-Suzzi, PhD

CONTACT

[email protected]

6312162993

Sponsors and collaborators

Lead sponsor

Alexander Stessin

Other

Collaborators

  • Northwell Health

Registry information

Official study title

Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Acronym: DEFINE

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Aug 14, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.