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

NCT02917421 | Active Not Recruiting Phase 1 Results DMC FDA Device

• 1 other identifier: 1602017017
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity Will be Measured by Evaluating the Number 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 number of patients who experience grade II-III dermatitis within 60 days of the end of treatment. Acute Toxicity will be graded using CTCAE v4.0.

  60 days from start of radiation therapy.

Secondary Outcomes (4)

• Change in Quality of Life of Patients.

  Baseline, end of radiation, 1 month post radiation.

• Late Radiation Toxicity in Treated Patients

  2 years and 5 years

• Number of Patients With Grades 2 or Higher Toxicity

  2 years and 5 years

• Quality of Life of Patients

  2 years

Other Outcomes (4)

• Overall Survival Will be Measured

  up to 10 years

• Molecular Signatures That Predict Fibrosis Will be Prospectively Measured From Blood Samples.

  10 years

• Local Control Rates Will be Measured.

  up to 10 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

(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

Cohort 2

EXPERIMENTAL

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

Interventions

Radiation RADIATION

(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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

New York Presbyterian Hospital - Queens

New York, New York, 10065, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, 11215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Dr.Silvia Formenti
• Organization: Weill Medical College

shc2043@med.cornell.edu

212-746-3608

Study Officials

• Silvia Formenti, M.D.

  Weill Cornell Medicine - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 28, 2016
• Study Start: December 19, 2016
• Primary Completion: May 19, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026
• Results First Posted: June 6, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)