Clinical trial NCT02917421: Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Official title: Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 88
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Primary outcomes:
measure: Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.
timeFrame: 60 days from start of radiation therapy.
Secondary outcomes:
measure: Change in Quality of Life of Patients.
timeFrame: Baseline, end of radiation, 1 month post radiation.
measure: Late Radiation Toxicity in Treated Patients
timeFrame: 2 years and 5 years
measure: Number of Patients With Grades 2 or Higher Toxicity
timeFrame: 2 years and 5 years
measure: Quality of Life of Patients
timeFrame: 2 years
Other outcomes:
measure: Overall Survival Will be Measured
timeFrame: up to 10 years
measure: Molecular Signatures That Predict Fibrosis Will be Prospectively Measured From Blood Samples.
timeFrame: 10 years
measure: Local Control Rates Will be Measured.
timeFrame: up to 10 years
measure: Distant Recurrences Will be Measured.
timeFrame: up to 10 years
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Brooklyn Methodist Hospital - NewYork Presbyterian
state: New York
Study officials:
affiliation: Weill Cornell Medicine - New York Presbyterian Hospital
name: Silvia Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: