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Alternative Treatment Approach (Radiation Therapy, then Mastectomy, then Immediate Reconstruction Surgery) for the Treatment of Invasive Breast Cancer
Trial Status: active
This phase I trial tests an alternative treatment approach that gives patients with invasive T3-4 breast cancer radiation therapy before surgical removal of all breast tissue (mastectomy) and performs immediate reconstruction surgery at the time of mastectomy. T3-4 breast cancer is when cancer has grown beyond the normal breast tissue and into the chest wall or skin or has become swollen and started to cause pain. T3-4 breast cancer is normally treated with chemotherapy followed by a mastectomy and removal of the axillary lymph nodes (lymph nodes in the armpit area). After the mastectomy, patients normally receive radiation therapy and then have breast reconstruction surgery many months to years after completing radiation therapy. Breast reconstruction surgery is typically delayed in order to minimize additional side effects from the mastectomy and radiation therapy. Reconstruction surgery is also a standard procedure, and it is used to re-create the breast after surgery. The immediate reconstruction surgery, referred to as immediate autologous reconstruction (IR,) is different than the standard reconstruction surgery performed on patients with T3-4 breast cancer. IR is a surgical procedure where immediately following mastectomy, the surgeon takes tissue from another part of the body and uses it to re-create the breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from the body. Giving radiation therapy, mastectomy, then IR may be more effective at shrinking tumors than the standard treatment approach and have fewer side effects.
Inclusion Criteria
Female sex, aged >= 18 years, with biopsy-proven invasive breast cancer
cT3-4 cN0-3 tumor
Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECIST version [v]1.1) definition
Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon
Able to read and understand English
Exclusion Criteria
Prior ipsilateral breast cancer
Bilateral breast cancer
Pregnant
Stage IV disease at presentation
Stable disease or progressive disease after NAC
Surgically unresectable breast disease
Body mass index (BMI) > 40
Prior history of thoracic radiotherapy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05412225.
I. Determine the feasibility of IR after neoadjuvant radiotherapy (NART) by assessing the rate of wound complications reported for current standard of care of post mastectomy radiotherapy (PMRT) and delayed reconstruction (surgical site infection [SSI], reoperative intervention, and flap failure).
SECONDARY OBJECTIVES:
I. Prospectively assess rates of lymphedema after NART and IR by use of perometry and arm measurements.
II. Determine the rate of pathologic complete response to treatment after following neoadjuvant chemotherapy (NAC) and NART.
III. Characterize breast satisfaction and quality of life by use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), BREAST-Q, and LYMPH-Q after NART and IR and assess the association between patient reported outcomes and clinical covariates.
IV. Assessment of associations of magnetic resonance (MR) imaging biomarkers for tumor microenvironment (TME) hypoxia and the co-adaptive mechanisms of angiogenic and metabolic switching identified by immunohistochemistry on pre-NART biopsy samples.
OUTLINE:
Beginning 4-6 weeks after standard chemotherapy, patients undergo radiation therapy over 10-15 minutes Monday-Friday for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after radiation therapy, patients undergo mastectomy, followed by immediate reconstruction surgery. Patients also undergo magnetic resonance imaging (MRI) and biopsy at screening.
After completion of study treatment, patients are followed up at 2, 6, and 14 weeks after surgery, then every 6 months for 2 years after reconstruction surgery.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
