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A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer

Phase 2
18 Years
Not Enrolling
Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Male Breast Cancer, Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate, Mucinous Ductal Breast Carcinoma, Papillary Ductal Breast Carcinoma, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Tubular Ductal Breast Carcinoma

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Trial Information

A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer


I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence
rates. Patients will be followed for a period of five years following completion of
radiation to determine these rates.

II. To determine the cosmetic outcome resulting from breast conserving surgery and breast


I. To determine if there are patient factors which limit a patient's suitability to receive
breast conserving therapy in the setting of multi-centric disease.

II. To determine patient satisfaction of breast conserving therapy as it pertains to their
overall treatment experience as measured by a questionnaire.

III. To evaluate wound healing and overall complication rate after radiation as a component
of breast conserving therapy.


Patients undergo breast-conserving surgery consisting of partial mastectomies followed by
external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, then every 3 months
for 1 year, every 6 months for 1 year, and then annually for 5 years.

Inclusion Criteria


- Patients with multicentric carcinoma (tumors in different quadrants of the breast or
tumors separated by at least 4 cm)

- All radiographically suspicious lesions must be biopsied and have histologically
confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary,
papillary, colloid (mucinous), or tubular histologies

- A maximum of two radiographically detected malignant lesions

- Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass
and the second lesion detected only on MRI, treated with lumpectomies; the MRI
detected lesion must be pathologically =< 1 cm

- Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary
dissection as deemed appropriate by the treating surgeon for all patients with
invasive cancer; no axillary lymph node sampling is needed for patients with DCIS

- Negative resection margins with at least a 2 mm margin from invasive and in-situ
cancer or a negative re-excision

- A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken

- Patients are eligible regardless of estrogen receptor, progesterone receptor, or
Her-2/neu amplification

- Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy
should be delivered first and radiation must begin no earlier than three weeks and no
later than eight weeks following completion of chemotherapy

- Signed study-specific informed consent prior to study entry


- Extensive intraductal component by the Harvard definition (i.e., more than 25% of the
invasive tumor is DCIS and DCIS present in adjacent breast tissue)

- Palpable or radiographically suspicious contralateral axillary, ipsilateral or
contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes
unless these are histologically confirmed negative

- Patients receiving neoadjuvant chemotherapy

- Patients with distant metastatic disease detected by radiographic imaging; specific
studies for systemic imaging should be obtained as directed by localized symptoms or
per available NCCN guidelines

- Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying
the mutation by BRCAPRO (44) risk assessment >= 50%

- Diffuse calcifications throughout the breast

- Patients with skin involvement or inflammatory breast cancer

- Patients with Paget's disease of the nipple

- Patients nonepithelial breast malignancies such as lymphoma or sarcoma

- Patients with collagen vascular disorders, specifically systemic lupus erythematosis,
scleroderma, or dermatomyositis

- Patients with psychiatric, neurologic, or addictive disorders that would preclude
obtaining informed consent

- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to
participation in this study

- Patients who are pregnant or lactating, due to potential fetal exposure to radiation
and unknown effects of radiation on lactating females

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ipsilateral breast tumor recurrence rates

Outcome Description:

Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years

Outcome Time Frame:

5 years after completion of radiation

Safety Issue:


Principal Investigator

William Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

October 2011

Related Keywords:

  • Ductal Breast Carcinoma in Situ
  • Estrogen Receptor-negative Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • HER2-positive Breast Cancer
  • Invasive Ductal Breast Carcinoma
  • Invasive Lobular Breast Carcinoma
  • Male Breast Cancer
  • Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
  • Mucinous Ductal Breast Carcinoma
  • Papillary Ductal Breast Carcinoma
  • Progesterone Receptor-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Tubular Ductal Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular
  • Breast Neoplasms, Male



Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UH-Chagrin Highlands Orange Village, Ohio  44122
UH-Westlake Westlake, Ohio  44145