An interventional study of post-mastectomy radiation therapy (PMRT) and tissue expander (TE) in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Treatment
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).
Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
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.
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
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
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
Participants enrolled from September 2009 through September 2012.
| Milestone | TE-ADM With PMRT |
|---|---|
| Started | 32 |
| Completed | 26 |
| Not completed | 6 |
| Withdrew: Death | 1 |
| Withdrew: Disease progression | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
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).
| percentage of participants | TE-ADM With PMRT |
|---|---|
| Success Rate | 65.4 (44.3 to 82.8) |
Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.
| percentage radiation dose to lung | TE-ADM With PMRT |
|---|---|
| Lung Dose-Volume | 28.7 (6.8 to 38.1) |
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.
| Participants | TE-ADM With PMRT |
|---|---|
| Excellent | 2 |
| Good | 17 |
| Fair | 5 |
| Poor | 0 |
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.
| Participants | TE-ADM With PMRT |
|---|---|
| IA | 0 |
| IB | 1 |
| II | 15 |
| III | 14 |
| IV | 1 |
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.
| Participants | TE-ADM With PMRT |
|---|---|
| IA | 0 |
| IB | 8 |
| II | 7 |
| III | 7 |
| IV | 0 |
Collected over Specific adverse events (AEs) as listed were evaluated and reported on the follow-up and cosmetic evaluation case report form at 6-, 12-, 18- and 24 months post RT. AEs were graded according to 5 classifications: mild, mild-moderate, moderate, moderate-severe and severe. Serious AEs were defined as AEs with a classification of moderate-severe or severe and other AEs with a classification of mild, mild-moderate or moderate.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TE-ADM With PMRT | 1/31 (3.2%) | 4/31 (12.9%) | 30/31 (96.8%) |
| Event | TE-ADM With PMRT |
|---|---|
| Delayed Healing WoundSkin and subcutaneous tissue disorders | 1/31 |
| InfectionInfections and infestations | 1/31 |
| DeflationReproductive system and breast disorders | 1/31 |
| AsymmetryReproductive system and breast disorders | 1/31 |
| Event | TE-ADM With PMRT |
|---|---|
| AsymmetryReproductive system and breast disorders | 26/31 |
| Pain/costochondritisMusculoskeletal and connective tissue disorders | 19/31 |
| HyperpigmentationSkin and subcutaneous tissue disorders | 15/31 |
| DeflationReproductive system and breast disorders | 3/31 |
| Skin IschemiaSkin and subcutaneous tissue disorders | 2/31 |
| Chronic DrainageSkin and subcutaneous tissue disorders | 2/31 |
| Delayed HealingSkin and subcutaneous tissue disorders | 1/31 |
| InfectionInfections and infestations | 1/31 |
| Age, Continuous(years) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Median | 42.3 (24.6 to 63.5) |
| Sex: Female, Male(Participants) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Female | 32 |
| Male | 0 |
| Breast Cancer Laterality(Participants) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Left | 15 |
| Right | 17 |
| Mastectomy (unilateral, bilateral)(Participants) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Unilateral | 18 |
| Bilateral | 14 |
| Number of Lymph Nodes Excised(lymph nodes) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Median | 11 (1 to 38) |
| Number of Lymph Nodes Involved(lymph nodes) | Tissue Expander and Acellular Dermal Matrix |
|---|---|
| Median | 2 (0 to 23) |
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Dana-Farber Cancer Institute