Clinical trial NCT01100489: Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
Official title: A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.

Detailed description: PRIMARY OBJECTIVES:

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 radiation.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Eligibility criteria: Inclusion

* 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

Exclusion

* 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

Primary outcomes:
measure: Ipsilateral breast tumor recurrence rates
timeFrame: 5 years after completion of radiation
measure: To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
timeFrame: at 1 year after radiation
Secondary outcomes:
measure: To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy
timeFrame: 5 years after completion of radiation treatment
measure: Patient satisfaction with the procedure as determined by a questionnaire
timeFrame: at 1 year after radiation
measure: To evaluate wound healing and overall complication rate after radiation
timeFrame: at one year after radiation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: William Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: