Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
NCT ID: NCT04871516
Last Updated: 2026-01-22
Study Results
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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ACTIVE_NOT_RECRUITING
NA
103 participants
INTERVENTIONAL
2021-05-18
2028-01-31
Brief Summary
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Detailed Description
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I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).
SECONDARY OBJECTIVE:
I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).
TERTIARY/EXPLORATORY OBJECTIVES:
I. To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.
II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.
III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.
IV. To study the cancer biology before and after radiation treatment.
OUTLINE:
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (radiation therapy boost, WBI)
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Boost
Undergo radiation therapy boost
Therapeutic Surgical Procedure
Undergo standard surgery
Whole Breast Irradiation
Undergo standard WBI
Breast MRI
A baseline breast MRI
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Boost
Undergo radiation therapy boost
Therapeutic Surgical Procedure
Undergo standard surgery
Whole Breast Irradiation
Undergo standard WBI
Breast MRI
A baseline breast MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically and radiographically node negative
* No indication of metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Synchronous bilateral invasive cancer allowed
* Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
* Willingness to participate in the clinical trial and adhere to the study protocol
* Individuals of all races, genders and ethnic groups are eligible for this trial
Exclusion Criteria
* Inflammatory breast cancer (cT4)
* Multicentric tumor
* Prior ipsilateral breast or thoracic RT
* Contraindication for baseline magnetic resonance imaging (MRI)
* Contraindication for surgery
* Distant metastatic disease
* Other synchronous cancer (besides bilateral breast)
* Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Bruce G Haffty
Professor and Chairman, Department of Radiation Oncology
Principal Investigators
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Bruce G Haffty
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Clara Maass Medical Center
Belleville, New Jersey, United States
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
Elizabeth, New Jersey, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2020-05711
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro2020001306
Identifier Type: -
Identifier Source: secondary_id
042005
Identifier Type: OTHER
Identifier Source: secondary_id
Pro2020001306
Identifier Type: -
Identifier Source: org_study_id
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