Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations

Study Overview
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Brief Summary
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This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

Detailed Description
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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.

Official Title
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Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): 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 Gy (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. Radiation therapy : 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 Gy (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. | Radiation: Radiation<br>* (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): 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 Gy (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.<br>|
| Experimental: Cohort 2<br>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) Radiation Therapy : 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 Gy (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. | Radiation: Radiation<br>* (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): 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 Gy (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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity will be measured by evaluating the proportion of patients who experience grade II-III dermatitis within 60 days of radiation therapy. | feasibility of accelerated radiotherapy in the post-operative setting of breast cancer patients treated by neo-adjuvant chemotherapy and surgery will be measured, by evaluating the proportion of patients who experience grade II-III dermatitis within 60 days of the end of treatment. | 60 days from start of radiation therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients at various time points. |  | Baseline and 5 years | 
| late radiation toxicity in treated patients | incidence of late radiation toxicity (brachial plexopathy, fibrosis and telangiectasia) will be evaluated and genetic determinants of breast fibrosis will be identified. | 5 years | 
| Proportion of patients with grades 2 or higher toxicity | Proportion of patients with grades 2 or higher toxicity | 5 years |