Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Not Recruiting

Trial ID: NCT03422003

Purpose

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. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.

Official Title

Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Stanford Investigator(s)

Kathleen Horst, MD
Kathleen Horst, MD

Professor of Radiation Oncology (Radiation Therapy)

Eligibility

Inclusion Criteria:

1. Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor
2. Has been treated with mastectomy
3. Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
4. 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)
5. Use of bolus is permitted, but not required
6. Age ≥18

Exclusion Criteria:

1. T4 cancer
2. Recurrent breast cancer or history of prior breast radiation therapy
3. 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
4. Pregnant or nursing
5. 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
6. Breast cancer requiring bilateral breast/chest wall radiation therapy.

Intervention(s):

radiation: Radiation Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elanor Catherine Irvine Brown
650-724-4606

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