Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Withdrawn

Phase 2

Conditions

Estrogen Receptor-positive Breast Cancer

Progesterone Receptor-negative Breast Cancer

Papillary Ductal Breast Carcinoma

Estrogen Receptor-negative Breast Cancer

Stage I Breast Cancer

HER2-positive Breast Cancer

Invasive Lobular Breast Carcinoma

Invasive Ductal Breast Carcinoma

HER2-negative Breast Cancer

Tubular Ductal Breast Carcinoma

Mucinous Ductal Breast Carcinoma

Male Breast Cancer

Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate

Stage II Breast Cancer

Progesterone Receptor-positive Breast Cancer

Ductal Breast Carcinoma in Situ

Treatments

Procedure: therapeutic conventional surgery

Other: questionnaire administration

Radiation: external beam radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01100489

CASE1109

NCI-2010-00644 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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