Clinical trial NCT02086578: Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients with Implant Reconstructions
Official title: Phase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients with Implant Reconstructions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: multi-beam Intensity-Modulated Radiation Therapy (IMRT)
14-028
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants.

The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.

Detailed description: Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).

Eligibility criteria: Inclusion Criteria:

* Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
* Histologically-confirmed invasive breast cancer by MSKCC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Status post mastectomy with surgical assessment of axillary nodes
* Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC
* If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.

Exclusion Criteria:

* Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)
* Pregnant or breastfeeding.
* Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
* Prior radiation therapy to the ipsilateral breast/nodes or thorax.
* The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol

Primary outcomes:
measure: efficacy of multi-beam IMRT
timeFrame: 30 months
Secondary outcomes:
measure: incidence of moderate to severe capsular contracture
timeFrame: 30 months
measure: rates of minor revisional surgeries
timeFrame: 2 years
measure: evaluate cosmesis
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Follow-Up only)
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daphna Gelblum, MD
role: PRINCIPAL_INVESTIGATOR
References: