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

Weill Cornell Medicine (WCM)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Radiation: Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02917421

1602017017

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Female

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Cohort 1

Experimental group

Description:

(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.

Treatment:

Radiation: Radiation

Cohort 2

Experimental group

Description:

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.

Treatment:

Radiation: Radiation