Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

NCT01664091 | Completed Results DMC

• 1 other identifier: 09-254
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).

Conditions

Breast Cancer

Keywords

tissue expander; acellular dermal matrix

Outcome Measures

Primary Outcomes (1)

• Success Rate

  Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).

  2 years

Secondary Outcomes (4)

• Lung Dose-Volume

  Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.

• Cosmetic Score

  2 years

• Baker Classification Peak Score

  Assessed up to 2 years post PMRT

• Baker Classification 2-Year Score

  2 Years

Study Arms (1)

TE-ADM with PMRT

EXPERIMENTAL

Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.

Radiation: post-mastectomy radiation therapy (PMRT); Device: tissue expander (TE); Device: acellular dermal matrix (ADM)

Interventions

post-mastectomy radiation therapy (PMRT) RADIATION

TE-ADM with PMRT

tissue expander (TE) DEVICE

TE-ADM with PMRT

acellular dermal matrix (ADM) DEVICE

TE-ADM with PMRT

Eligibility Criteria

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

You may qualify if:

• Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3 invasive tumors recently treated with mastectomy
• Patients must have had immediate reconstruction with a TE and ADM
• Participants must be candidates for postmastectomy radiation therapy (RT). Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1 (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2 tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors
• Axillary nodes may be positive or negative
• Microscopically positive margins are permitted
• Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is permitted
• Patients must agree to return for scheduled follow-up visits with their radiation oncologist 6, 12, 18 and 24 months after RT (+/- 1 month)
• years of age or older

You may not qualify if:

• Participants with T4 tumors
• Participants with recurrent breast cancer or a history of prior breast RT
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• HIV-positive individuals on combination antiretroviral therapy

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tissue Expansion Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Surgical Equipment

Limitations and Caveats

The major limitation of this study was its small sample size and its single arm nature.

Results Point of Contact

• Title: Julia Wong, MD
• Organization: Dana-Farber Cancer Institute

JWONG@LROC.HARVARD.EDU

617-632-3591

Study Officials

• Julia Wong, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: August 14, 2012
• Study Start: September 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 26, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)