Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation
Overview
- Phase
- Not Applicable
- Intervention
- Phase II - Preoperative Radiation followed by Lumpectomy.
- Conditions
- Breast Cancer
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Postoperative Complications Following
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.
Detailed Description
This study will examine the feasibility, complication rates, cosmetic results and local control rate of 3D conformal radiation therapy (CRT) confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. This study also will test the feasibility of MRI-based treatment planning for preoperative accelerated partial breast irradiation and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol. It will also look at overall survival rates. Correlative studies include measuring the changes in tumor gene expression and immune response to radiation therapy and correlate this with pathologic response.
Investigators
Adam Currey
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
- •Age ≥40 years
- •Estrogen receptor positive
- •Patients with both her2 positive and her2 negative tumors are eligible
- •Unifocal disease
- •Invasive ductal carcinoma diagnosed by core needle biopsy
- •Clinically node negative both by physical exam and by ultrasound. All enlarged or abnormal appearing lymph nodes must be biopsied.
- •Zubrod performance status 0-2
- •Study entry must be within 120 days from initial diagnosis of breast cancer.
- •Complete blood count (CBC) /differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: Absolute neutrophil count ≥ 1,800 cells/mm\^3; Platelets ≥ 75,000 cells/mm\^3; Hemoglobin ≥8.0g/dl.
Exclusion Criteria
- •American Joint Committee on Cancer (AJCC) clinical T3, N1-3, M1, stage IIB, stage III or stage IV breast cancer
- •Prior invasive non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix, or prior contralateral breast cancer as described in 3.1.11) unless disease free and off treatment for a minimum of five years prior to study entry.
- •Multifocal breast cancer
- •Modified Bloom-Richardson grade 3 disease
- •Estrogen receptor negative disease
- •Lymphovascular space invasion noted on biopsy
- •Invasive lobular carcinoma
- •Purely non-invasive breast cancer (i.e. ductal carcinoma in situ, lobular carcinoma in situ)
- •Non-epithelial breast malignancies such as sarcoma or lymphoma
- •Paget's disease of the nipple
Arms & Interventions
Radiation Therapy followed by Lumpectomy
Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy
Intervention: Phase II - Preoperative Radiation followed by Lumpectomy.
Outcomes
Primary Outcomes
Postoperative Complications Following
Time Frame: 3 Months
The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.
Secondary Outcomes
- Overall Survival(5 Years)
- Re-excision of Tumor.(5 Years)