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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02086578
First received: March 11, 2014
Last updated: October 23, 2014
Last verified: October 2014

March 11, 2014
October 23, 2014
March 2014
March 2018   (final data collection date for primary outcome measure)
efficacy of multi-beam IMRT [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
The treatment would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).
Same as current
Complete list of historical versions of study NCT02086578 on ClinicalTrials.gov Archive Site
  • incidence of moderate to severe capsular contracture [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    will be examined using proportions of patients who developed Baker's grade <2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered.
  • incidence of minor revisional surgeries [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incidence of minor revisional surgeries by plastic surgeon will be evaluated by proportions too. Again, the rates (proportions) will be compared across the two groups.
  • evaluate cosmesis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time.
Same as current
Not Provided
Not Provided
 
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
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

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. Currently, the standard way 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.

Patients will undergo mastectomy + axillary dissection with immediate tissue expander placement. As is the current practice at our institution, patients who receive 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 no sooner than 6 months ± 2 weeks following radiation.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Device: Breast MRI
  • Behavioral: Breast-Q© questionnaire
  • Radiation: Multi-Beam IMRT
    The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
  • Experimental: Group 1
    Physical examination by MD, Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-ammonia PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-ammonia as a perfusion tracer. A follow-up 13N-ammonia PET study with low-dose CT for attenuation correction will be obtained 12-18 months post-IMRT.
    Interventions:
    • Device: Breast MRI
    • Behavioral: Breast-Q© questionnaire
    • Radiation: Multi-Beam IMRT
  • Experimental: Group 2
    Physical examination by MD, Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant no sooner than 6 months following the completion of radiation. Total length of the follow-up time will be 30 ± 2 months post-IMRT
    Interventions:
    • Device: Breast MRI
    • Behavioral: Breast-Q© questionnaire
    • Radiation: Multi-Beam IMRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
155
Not Provided
March 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female 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
  • Will be receiving comprehensive PMRT, including the axillary, supraclavicular, and internal mammary nodes, at MSKCC

Exclusion Criteria:

  • Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)
  • Patients with nipple-sparing mastectomy
  • 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.
Female
18 Years and older
No
Contact: Alice Ho, MD 212-639-6773
Contact: Babak Mehrara, MD 212-639-8639
United States
 
NCT02086578
14-028
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Alice Ho, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP