Breast Cancer Clinical Trial
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Summary
This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Full Description
Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy x 15 fractions (40.50 Gy) with a concomitant boost of 0.50 (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes.
In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy).
Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.
Eligibility Criteria
The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC.
Inclusion Criteria:
Age older than 18
Pre- or post-menopausal women with Stage I-III breast cancer
Status post neoadjuvant systemic therapy
Status post-chemotherapy breast surgery
Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm (patients with focally positive margin are not excluded).
Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed).
Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Exclusion Criteria:
Previous radiation therapy to the ipsilateral breast and/or nodal area
Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
Pregnant or lactating women
Concurrent chemotherapy, with the exception of anti HER2neu therapies
Inadequate axillary dissection in a setting of positive sentinel node
Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.
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There are 2 Locations for this study
New York New York, 10065, United States More Info
Principal Investigator
New York New York, 11215, United States More Info
Principal Investigator
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