Status:
UNKNOWN
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the...
Detailed Description
PRIMARY OBJECTIVE: 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 surge...
Eligibility Criteria
Inclusion
- Breast cancer patients with biopsy proven invasive cancer
- 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
- Need for neoadjuvant chemotherapy
- 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
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04871516
Start Date
May 18 2021
End Date
January 31 2024
Last Update
April 21 2023
Active Locations (11)
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1
Clara Maass Medical Center
Belleville, New Jersey, United States, 07109
2
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
Elizabeth, New Jersey, United States, 07202
3
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States, 08690
4
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302