Active, not recruitingNCT02917421ARTUpdated Apr 17, 2026Results posted

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

A Phase 1/2 interventional study of Radiation in Breast Cancer, sponsored by Weill Medical College of Cornell University. Active, not recruiting at 3 sites in United States. Open to female participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Weill Medical College of Cornell University · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 88
Allocation: Randomized
Ages: 19 Years to 99 Years
Sex: Female

Study summary

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

Read the 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.

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 88 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 99 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 88 participants (actual)

Study arms

Experimental
Cohort 1
(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
Experimental
Cohort 2
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

RadiationRadiation
(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.

What researchers measure

Primary outcomes

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.
Time frame: 60 days from start of radiation therapy.

Secondary outcomes

Change in Quality of Life of Patients.
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic and functional outcomes after breast radiation therapy. The score value ranges from 1.00 - 4.00, with a higher score reflecting a poorer outcome. Following is the criteria for evaluating breast radiation therapy outcomes in patients: good (1.00-1.75) ; intermediate (1.76-2.50), fair (2.51 -3.25) and poor (3.26 - 4.00).
Time frame: Baseline, end of radiation, 1 month post radiation.
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.
Time frame: 2 years and 5 years
Number of Patients With Grades 2 or Higher Toxicity
Number of patients with grades 2 or higher toxicity
Time frame: 2 years and 5 years
Quality of Life of Patients
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic and functional outcomes after breast radiation therapy. The score value ranges from 1.00 - 4.00, with a higher score reflecting a poorer outcome. Following is the criteria for evaluating breast radiation therapy outcomes in patients: good (1.00-1.75) ; intermediate (1.76-2.50), fair (2.51 -3.25) and poor (3.26 - 4.00).
Time frame: 2 years

Other outcomes

Overall Survival Will be Measured
Time frame: up to 10 years
Molecular Signatures That Predict Fibrosis Will be Prospectively Measured From Blood Samples.
The purpose of this portion of the study will be to collect blood from each subject accrued to the study and willing to donate a specimen of blood for research, to study the TGF-β1 polymorphisms that have been reported to be correlated with the development of fibrosis following radiotherapy for treatment of breast cancer.
Time frame: 10 years
Local Control Rates Will be Measured.
Time frame: up to 10 years
Distant Recurrences Will be Measured.
Time frame: up to 10 years

Results

Posted Jun 6, 2024

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1	Cohort 2
Started	47	41
Completed	47	41
Not completed	0	0

Outcome measures

PrimaryAcute 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.

Time frame:: 60 days from start of radiation therapy.
Reported as:: Count of participants · Participants

Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.
Participants	Cohort 1	Cohort 2
Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.	0	0

SecondaryChange in Quality of Life of Patients.

The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic and functional outcomes after breast radiation therapy. The score value ranges from 1.00 - 4.00, with a higher score reflecting a poorer outcome. Following is the criteria for evaluating breast radiation therapy outcomes in patients: good (1.00-1.75) ; intermediate (1.76-2.50), fair (2.51 -3.25) and poor (3.26 - 4.00).

Time frame:: Baseline, end of radiation, 1 month post radiation.
Reported as:: Mean · score on a scale

Change in Quality of Life of Patients.
score on a scale	Cohort 1	Cohort 2
Baseline	1.62 ± 0.730	1.92 ± 0.979
End of Radiation	1.80 ± 0.876	1.82 ± 0.855
1 month post radiation	1.59 ± 0.730	1.79 ± 0.812

SecondaryLate 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.

Time frame:: 2 years and 5 years