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Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

Phase 2
40 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)



- To assess the local recurrence (LR) rate with breast-conservation in patients with
multiple ipsilateral primary breast cancer (MIBC).


- 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

- 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

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.

Inclusion Criteria


- Upon clinical exam and pre-operative imaging by MRI and mammogram both, two or three
foci of biopsy-proven breast cancer separated by ≥ 3 cm of normal breast tissue on
clinical exam and preoperative imaging; foci must include at least one focus of
invasive breast carcinoma with another focus of either invasive breast carcinoma or
ductal carcinoma in situ (DCIS); no more than 2 quadrants with biopsy-positive breast

- Ultrasound cannot be used to determine patient eligibility; eligibility to be
determined by bilateral mammogram and MRI only

- Bilateral mammogram ≤ 60 days prior to registration

- Bilateral breast MRI ≤ 45 days prior to registration

- cN0 or cN1 disease

- No cNX, cN2, or cN3 disease

- Willing to provide tissue samples for correlative research purposes

- Largest single focus of disease > 5 cm by either mammogram or MRI or both
(measurement of the largest single focus should include any satellite lesions within
1 cm of the index lesion)

- No clinical or radiographic evidence of metastatic disease

- No prior or current lobular carcinoma in situ (LCIS), DCIS, or invasive breast cancer
in the opposite breast (i.e., bilateral disease is not allowed)

- No patients with known BRCA mutations


- Life expectancy of at least 5 years, excluding diagnosis of breast cancer (comorbid
conditions should be taken into consideration, but breast cancer diagnosis is not a

- Men are excluded from this study

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

- Hemoglobin (Hgb) ≥ 8 g/dL

- Peripheral platelet count (PLT) ≥ 50,000/mm³

- Ability to complete questionnaire(s) by themselves or with assistance

- Willing to return to enrolling institution for follow-up during the Active Monitoring
Phase (the active treatment and observation portions) of the study

- Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women
of childbearing potential only

- None of the following:

- Pregnant women

- Nursing women

- Women of childbearing potential who are unwilling to employ adequate
contraception (as determined by the treating physician)

- No co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would interfere significantly with whole-breast
irradiation (such as connective tissue disorders, lupus, or scleroderma)

- No 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

- No other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic
skin cancer or carcinoma-in-situ of the cervix

- If there is a history of prior malignancy, they must not be receiving other
specific treatment for their cancer


- No surgical axillary staging procedure prior to study entry

- Fine-needle aspiration (FNA) or core-needle biopsy of axillary node is permitted

- No breast implants at time of diagnosis

- Patients who have had implants previously removed prior to diagnosis are

- No treatment including radiation therapy, chemotherapy, biotherapy, or hormonal
therapy for this cancer prior to registration

- No neoadjuvant endocrine therapy or neoadjuvant hormonal therapy

- No planned partial-breast radiation

- No administration of any investigational agent ≤ 30 days prior to registration

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Judy Boughey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

July 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • Breast Neoplasms



Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Doctor's Hospital of LaredoLaredo, Texas  78041
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
McFarland Clinic, PCAmes, Iowa  50010
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Billings Clinic - DowntownBillings, Montana  59107-7000
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Union Hospital of Cecil CountyElkton MD, Maryland  21921
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
CCOP - Kansas CityPrairie Village, Kansas  66208
Nashville Breast CenterNashville, Tennessee  37203
Clarian West Medical CenterAvon, Indiana  46123
Clarian North Medical CenterCarmel, Indiana  46032
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405