Status:
UNKNOWN
Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Weill Medical College of Cornell University
Sunnybrook Health Sciences Centre
Conditions:
Early Stage Breast Carcinoma
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Radiation therapy after surgery to remove breast cancer improves control of the breast cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation to the entire breast...
Detailed Description
Our proposal represents the convergence of several recent developments in the treatment of patients with low-risk carcinoma of the breast. For the selected subset of patients with low-risk disease, it...
Eligibility Criteria
Inclusion
- Age ≥ 50 years and postmenopausal
- Tumor size \< 3cm on pre-treatment imaging
- Any grade of disease, estrogen receptor (ER) positive
- Unicentric/unifocal disease
- Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
- Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
- Surgical expectation that a \> 2mm margin can be obtained.
- Lesion is 1 cm or greater from the skin surface.
- Able to have surgery within 14-20 days of radiation therapy.
- Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.
Exclusion
- Previous RT to the same breast
- Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
- Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
- Distant metastases
- Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
- Prior non-hormonal therapy or radiation therapy for the current breast cancer
- Patients with Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Patients with a breast technically unsatisfactory for radiation therapy.
- Inability to lie prone with arms raised above head for extended periods of time.
- Patients not appropriate for breast conserving surgery due to expectation of poor cosmetic result, even without RT
- Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
- Inability or unwillingness to provide informed consent.
- Any other malignancy at any site (except non-melanomatous skin cancer) \< 5 years prior to study enrollment
- Patients who are pregnant or lactating
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT02212860
Start Date
March 1 2015
End Date
April 1 2024
Last Update
December 22 2023
Active Locations (1)
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1
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6