Breast Cancer
Conditions
Keywords
tissue expander, acellular dermal matrix
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).
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).
Interventions
RADIATIONpost-mastectomy radiation therapy (PMRT)
DEVICEtissue expander (TE)
DEVICEacellular dermal matrix (ADM)
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms. |
| Cosmetic Score | 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. |
| Baker Classification Peak Score | 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. |
| Baker Classification 2-Year Score | 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. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled from September 2009 through September 2012.
Participants by arm
| Arm | Count |
|---|---|
| Tissue Expander and Acellular Dermal Matrix immediate reconstruction with a TE and ADM followed by PMRT
radiation: The prescribed chest-wall dose will be 50 - 50.4 Gy in 25-28 fractions, given once daily over 5-7 weeks. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Age, Continuous | 42.3 years |
| Breast Cancer Laterality Left | 15 Participants |
| Breast Cancer Laterality Right | 17 Participants |
| Mastectomy (unilateral, bilateral) Bilateral | 14 Participants |
| Mastectomy (unilateral, bilateral) Unilateral | 18 Participants |
| Number of Lymph Nodes Excised | 11 lymph nodes |
| Number of Lymph Nodes Involved | 2 lymph nodes |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 31 |
| other Total, other adverse events | 30 / 31 |
| serious Total, serious adverse events | 4 / 31 |
Outcome results
Primary
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).
Time frame: 2 years
Population: The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TE-ADM With PMRT | Success Rate | 65.4 percentage of participants |
Secondary
Baker Classification 2-Year Score
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.
Time frame: 2 Years
Population: The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TE-ADM With PMRT | Baker Classification 2-Year Score | IA | 0 Participants |
| TE-ADM With PMRT | Baker Classification 2-Year Score | IB | 8 Participants |
| TE-ADM With PMRT | Baker Classification 2-Year Score | II | 7 Participants |
| TE-ADM With PMRT | Baker Classification 2-Year Score | III | 7 Participants |
| TE-ADM With PMRT | Baker Classification 2-Year Score | IV | 0 Participants |
Secondary
Baker Classification Peak Score
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.
Time frame: Assessed up to 2 years post PMRT
Population: The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TE-ADM With PMRT | Baker Classification Peak Score | IB | 1 Participants |
| TE-ADM With PMRT | Baker Classification Peak Score | IA | 0 Participants |
| TE-ADM With PMRT | Baker Classification Peak Score | II | 15 Participants |
| TE-ADM With PMRT | Baker Classification Peak Score | III | 14 Participants |
| TE-ADM With PMRT | Baker Classification Peak Score | IV | 1 Participants |
Secondary
Cosmetic Score
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.
Time frame: 2 years
Population: The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TE-ADM With PMRT | Cosmetic Score | Excellent | 2 Participants |
| TE-ADM With PMRT | Cosmetic Score | Good | 17 Participants |
| TE-ADM With PMRT | Cosmetic Score | Fair | 5 Participants |
| TE-ADM With PMRT | Cosmetic Score | Poor | 0 Participants |
Secondary
Lung Dose-Volume
Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.
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.
Population: The analysis population is comprised of all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TE-ADM With PMRT | Lung Dose-Volume | 28.7 percentage radiation dose to lung |