Status:
ACTIVE_NOT_RECRUITING
Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction....
Detailed Description
Over 180,000 diagnoses of invasive breast cancer are made in the US each year. Over one-third of women with early stage and over half with late-stage breast cancer are treated with mastectomy (removal...
Eligibility Criteria
Inclusion
- Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor
- Has been treated with mastectomy
- Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
- Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)
- Use of bolus is permitted, but not required
- Age ≥18
Exclusion
- T4 cancer
- Recurrent breast cancer or history of prior breast radiation therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient's ability to participate in this study
- Pregnant or nursing
- History of a different malignancy except for the following circumstances:
- Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (\<5 %).
- Cervical cancer in situ and basal cell or squamous cell carcinoma of the skin
- Breast cancer requiring bilateral breast/chest wall radiation therapy.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03422003
Start Date
April 1 2018
End Date
April 1 2030
Last Update
November 1 2024
Active Locations (15)
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1
University of California, San Francisco
San Francisco, California, United States, 94115
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Vail Health
Edwards, Colorado, United States, 81632
4
Yale Cancer Center
New Haven, Connecticut, United States, 06511