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Definitive Radiation Therapy for Inoperable Breast Cancer

NCT ID: NCT07122713

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2033-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Breast Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

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

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)

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type RADIATION

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role collaborator

Alexander Stessin

OTHER

Sponsor Role lead

Responsible Party

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Alexander Stessin

Professor, Department of Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alexander Stessin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

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Stony Brook University Cancer Center

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Caterina Stony Brook Cancer Center Clinical Trials

Role: CONTACT

[email protected]
631-728-7425

Caterina Vacchi-Suzzi, PhD

Role: CONTACT

[email protected]
6312162993

Facility Contacts

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Cancer Clinical Trials Office

Role: primary

[email protected]
(631)-728-7425

Role: backup

[email protected]

Other Identifiers

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IRB2024-00364

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-BREAST-DEFINE

Identifier Type: -

Identifier Source: org_study_id