Breast Cancer Clinical Trial
Official title:
A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy
This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved.
Primary objective:
To assess the proportion of successful initial phase of tissue expander/implant based breast
reconstructions (no reconstruction failure or unexpected return to the operating room)
following post-mastectomy radiation therapy in participants with AeroFormplaced.
Secondary objectives:
- To evaluate the rate of successful exchange of tissue expander for implant
- To evaluate the rate of reconstruction revisions
- To evaluate CTCAE acute and chronic toxicity rates, infections and cosmetic outcomes
- To evaluate dosimetry to treatment targets as well as organs at risk (heart, lungs) with
AeroFormas compared to traditional reconstruction techniques.
- To evaluate time to initiation of chemotherapy and/or radiotherapy.
- To evaluate clinical outcomes-local recurrence, regional recurrence, distant metastases,
survival
- To evaluate participant breast reconstruction related QOL with the AirXpander
AeroFormdevice
This is a phase II trial evaluating the use of the intervention in participants with breast
cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile
and associated subsequent successful surgical reconstruction rate
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