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

NCT02086578 | Completed Phase 2 Results

• 1 other identifier: 14-028
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

multi-beam Intensity-Modulated Radiation Therapy (IMRT); 14-028

Outcome Measures

Primary Outcomes (1)

• Incidence of Implant Failure

  The multi-beam IMRT 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).

  24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2

Secondary Outcomes (3)

• Incidence of Moderate to Severe Capsular Contracture

  24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2

• Rates of Minor Revisional Surgeries

  2 years

• Evaluate Cosmesis

  Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo))

Study Arms (2)

Group 1

EXPERIMENTAL

Physical examination by MD, optional 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-NH3 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-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.

Device: Breast MRI; Behavioral: Breast-Q© questionnaire; Radiation: Multi-Beam IMRT

Group 2

EXPERIMENTAL

Physical examination by MD, optional 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 approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT

Device: Breast MRI; Behavioral: Breast-Q© questionnaire; Radiation: Multi-Beam IMRT

Interventions

Breast-Q© questionnaire BEHAVIORAL

Group 1; Group 2

Multi-Beam IMRT RADIATION

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.

Group 1; Group 2

Breast MRI DEVICE

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau (Follow-Up only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Daphna Gelblum, MD
• Organization: Memorial Sloan Kettering Cancer Center

gelblumd@MSKCC.ORG

914-367-7273

Study Officials

• Daphna Gelblum, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: March 11, 2014
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2024-09

Locations

US (7)