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

August 22, 2019 updated by: Julia S. Wong, MD, Dana-Farber Cancer Institute

An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • ADMs have been used in combination with a tissue expander and radiotherapy but have not been studied formally in terms of their ability to avoid complications sometimes seen with other methods of reconstruction and improve the delivery of the radiation. The only difference between being on the study and not being on the study is that the research team will analyze the records of those who participate to see how easy it was to give the radiation, how good the cosmetic outcome of the reconstruction is and what, if any, complications occured.
  • A minimum of 6 weeks between the surgery and the start of radiation therapy is required to allow for adequate healing. Often this interval will be longer, as many patients will receive chemotherapy in the interim. There is no maximum time from surgery to radiation.
  • Around the time of radiation planning, the radiation oncologist and plastic surgeon will agree upon how much deflation of the tissue expander will be required to permit simulation of the radiation therapy.
  • Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given once daily Monday through Friday over 5-7 weeks.
  • After the completion of the radiation therapy, the tissue expander will be re-expanded and eventually replaced by the permanent implant or flap reconstruction at the discretion of the plastic surgeon.
  • Participants will be expected to return to the Radiation Oncology Clinic for follow-up visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of cosmetic results and complications will be done at these visits using a recognized scoring system and photographs taken at each time point and scored for specific items (necrosis, telangiectasia, etc).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • 18 years of age or older

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TE-ADM with PMRT
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung Dose-Volume
Time Frame: Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.
Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.
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
Time Frame: 2 years
Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.
2 years
Baker Classification Peak Score
Time Frame: Assessed up to 2 years post PMRT
An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
Assessed up to 2 years post PMRT
Baker Classification 2-Year Score
Time Frame: 2 Years
An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Wong, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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