Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)
OBJECTIVES:
Primary
- To assess the local recurrence (LR) rate with breast-conservation in patients with
multiple ipsilateral primary breast cancer (MIBC).
Secondary
- To examine the conversion rate to mastectomy secondary to persistent positive margins;
poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or
inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed
of each site of disease.
- To assess patient's perception of cosmesis and incidence of breast lymphedema.
- To examine the type and severity of adverse effects of BCS and radiation for women with
MIBC.
- To examine the radiation-related side effects of whole-breast radiation with a boost to
1 large or > 1 lumpectomy site.
- To evaluate protein and gene expression patterns in tissue taken from each breast
lesion and to evaluate the concordance of the findings between these lesions.
- To compare the extent of disease described on imaging (mammography, bilateral breast
magnetic resonance imaging [MRI] and other adjunctive imaging modalities) with surgical
findings.
OUTLINE: This is a multicenter study.
Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative
margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the
surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion
of the treating medical oncologist based on tumor characteristics.
Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy,
patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed
of each site of disease 5 days a week for approximately 6 weeks.
Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire
5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next
3 years after WBI. Patients' surgeons also complete the questionnaire 5-30 days after
performing final surgery to assess cosmetic outcomes.
Formalin-fixed paraffin-embedded (FFPE) tissue block from each site of disease are collected
during BCS for protein and gene expression pattern studies. Blood samples may be also
collected at baseline and during BCS.
After completion of study treatment, patients are followed up every 6 months for 2 years and
then yearly for years 3-5.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years
No
Judy Boughey, MD
Study Chair
Mayo Clinic
Unspecified
CDR0000728605
NCT01556243
July 2012
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
CCOP - Kansas City | Prairie Village, Kansas 66208 |
Nashville Breast Center | Nashville, Tennessee 37203 |
Clarian West Medical Center | Avon, Indiana 46123 |
Clarian North Medical Center | Carmel, Indiana 46032 |
Benefis Sletten Cancer Institute | Great Falls, Montana 59405 |