Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

This is an interventional treatment trial for Breast Cancer focused on measuring histologically proven, invasive adenocarcinoma of breast, node negative (N0), breast-conserving surgery, negative for Her-2 amplification, estrogen receptor (ER) positive, progesterone receptor (PR) positive Read More

Inclusion Criteria:

• Understand and voluntarily sign an informed consent document prior to conducting any study related assessments or procedures.
• Histologically proven invasive adenocarcinoma of breast.
• Must have marker clip indicating location of target tumor in breast.
• Unifocal tumor less than or equal to 2 cm based on contrast-enhanced prone-breast MRI.
• Must be clinically and radiographically node negative (N0) to participate on this protocol. Clinically suspicious regional nodes by imaging or physical exam require biopsy evaluation to exclude disease involvement.
• Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment.
• Females age ≥ 50 years.
• Able to tolerate prone body positioning during radiation therapy.
• No prior ipsilateral-breast or thoracic radiotherapy.
• As defined on MRI, target lesion must be at least 10 mm distance from skin (defined as volume encompassing first 3 mm from breast surface).
• Must be estrogen receptor (ER) positive.
• Must be negative for Her-2 amplification. (Either 1+ on semi-quantitative evaluation of immunostain or negative by fluorescent in-situ hybridization).
• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.
• No history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.
• Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery.
• ECOG performance status less than 2.
• Females of childbearing potential must have a negative urine pregnancy test prior to simulation and within seven days of SABR start.

Exclusion Criteria:

• Have invasive lobular carcinoma.
• Have a Tumor > 2 cm as measured on prone contrast-enhanced breast MRI.
• Have presence of histologically proven lymph node disease.
• Are not a candidate for breast conserving surgery.
• Have had prior ipsilateral-breast or thoracic radiotherapy.
• History of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment.
• An MRI defined target tumor that is within 10 mm of skin (defined as volume encompassing first 3 mm from skin surface).
• Have amplification of Her-2 (Either 3+ by semi-quantitative immunostain or positive by Fluorescent in-situ hybridization (FISH)).
• Have implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.
• History of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.
• Have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery.
• A known carrier of BRCA1 or BRCA2 gene mutation.
• Pregnant or unwilling to undergo pregnancy screening.