Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed Description
PRIMARY OBJECTIVES: Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy. SECONDARY OBJECTIVES: 1. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position. 2. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position. 3. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position. 4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI OUTLINE: Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy. After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.
Investigators
Sasha Beyer
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- •The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- •Patient must be ≥ 50 years
- •Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.
- •Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.
- •The patient must have clinical node negative, stage I breast cancer.
- •The surgical treatment must be intended to be a lumpectomy
- •The biopsy site must have been demarcated by a clip(s)
- •Gross disease must be unifocal on Mammo/ MRI imaging
- •Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
- •Patient must be able to tolerate lying in the prone position with arms extended forward.
Exclusion Criteria
- •Age \< 50 years
- •Hormone unresponsive breast cancer
- •T-2 ( \> 3.0 cm), T-3, Stage III, or Stage IV breast cancer.
- •N-1, N-2, or N-3 clinical axillary nodes
- •Mastectomy intended
- •Unwilling to undergo anti-endocrine therapy
- •Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Paget's disease of the nipple
- •Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by \> 4 centimeters.
Outcomes
Primary Outcomes
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Time Frame: 4-6 weeks post-APBI
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
Secondary Outcomes
- Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0(Up to 5 years)
- Cosmetic outcome by the physician and patient(At year 3)
- Disease free survival(Up to 5 years)
- Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs(Up to 4 weeks post-surgery)
- Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0(Up to 4 weeks post-surgery)
- In-breast recurrence(Up to 5 years)
- Regional recurrence(Up to 5 years)
- Distant metastases(Up to 5 years)
- Overall survival(Up to 5 years)