Breast CancerPhase 1/2ARTNCT02917421
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
A Phase 1/2 study testing Radiation in people with Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Dec 2016to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
New York Presbyterian Hospital - Queens
New York, New York, 10065
Weill Cornell Medical College
New York, New York, 10065
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, 11215
About this study
Official title: Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study
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
- Breast Cancer
- Being tested
- Radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 60 days from start of radiation therapy.
Secondary outcomes (13)
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).
Measured: Baseline, end of radiation, 1 month post radiation.
Late Fibrosis Radiation Toxicity in Treated Patients
The percentage of participants who developed late radiation fibrosis following radiation therapy within the specified time frame period. Late fibrosis radiation toxicity was scored using the RTOG/EORTC and LENT/SOMA classification. Fibrosis was graded according to increasing severity of tissue changes: Grade 0 = no fibrosis; Grade 1 = barely palpable or increased tissue density; Grade 2 = definite increased tissue density and firmness; Grade 3 = very marked increased tissue density with retraction and/or fixation. Higher grades indicate greater severity of late radiation fibrosis and therefore worse outcomes, whereas Grade 0 represents the best outcome.
Measured: 2 years
Late Fibrosis Radiation Toxicity in Treated Patients
incidence of late fibrosis radiation toxicity scored using the RTOG/EORTC and LENT/SOMA classification
Measured: 5 years
Number of Patients With Grades 2 or Higher Toxicity
Number of patients with grades 2 or higher toxicity scored using the RTOG/EORTC and LENT/SOMA classification
Measured: 2 years
Number of Patients With Grades 2 or Higher Toxicity
Number of patients with grades 2 or higher toxicity scored using the RTOG/EORTC and LENT/SOMA classification
Measured: 5 years
Late Telangiectasia Radiation Toxicity in Treated Patients
The percentage of participants who developed late radiation telangiectasia following radiation therapy within the specified time frame period. Late radiation telangiectasia was scored using the RTOG/EORTC and LENT/SOMA classification. Telangiectasia was graded according to the extent of the affected skin area: Grade 0, none; Grade 1, <1 cm²; Grade 2, 1-4 cm²; Grade 3, >4 cm². Higher grades indicate greater severity of late radiation telangiectasia and therefore worse outcomes, whereas Grade 0 represents the best outcome.
Measured: 2 years
Late Telangiectasia Radiation Toxicity in Treated Patients
incidence of late telangiectasia radiation toxicity scored using the RTOG/EORTC and LENT/SOMA classification
Measured: 5 years
Quality of Life of Patients - Aesthetic Outcome
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 2 years
Quality of Life of Patients - Aesthetic Outcome
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 5 years
Quality of Life of Patients - Functional Outcome
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 2 years
Quality of Life of Patients - Functional Outcome
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 5 years
Quality of Life of Patients - Breast-specific Pain
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 2 years
Quality of Life of Patients - Breast-specific Pain
The patient reported outcomes or quality of life questionnaires are assessed for the aesthetic, functional and breast-specific pain 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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start19 Dec 2016
- Primary completion19 May 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Formenti, M.D., Principal investigator, Weill Cornell Medicine - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917421
- Sponsor's protocol ID
- 1602017017
- Acronym
- ART
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2016
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02917421
- Acronym / sponsor ID
- ART / 1602017017
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | 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. 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. |
| Cohort 2 | Experimental | Radiation: RadiationIn 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. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Cohort 1, Cohort 2 |
Primary outcome
Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy.
Time frame: within 60 days from start 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.
13 secondary outcomes
Change in Quality of Life of Patients.
Time frame: Baseline, end of radiation, 1 month post radiation.
Late Fibrosis Radiation Toxicity in Treated Patients
Time frame: 2 years
Late Fibrosis Radiation Toxicity in Treated Patients
Time frame: 5 years
Number of Patients With Grades 2 or Higher Toxicity
Time frame: 2 years
Number of Patients With Grades 2 or Higher Toxicity
Time frame: 5 years
Late Telangiectasia Radiation Toxicity in Treated Patients
Time frame: 2 years
Late Telangiectasia Radiation Toxicity in Treated Patients
Time frame: 5 years
Quality of Life of Patients - Aesthetic Outcome
Time frame: 2 years
Quality of Life of Patients - Aesthetic Outcome
Time frame: 5 years
Quality of Life of Patients - Functional Outcome
Time frame: 2 years
Quality of Life of Patients - Functional Outcome
Time frame: 5 years
Quality of Life of Patients - Breast-specific Pain
Time frame: 2 years
Quality of Life of Patients - Breast-specific Pain
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Formenti, M.D. principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation in people with Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy. (time frame: within 60 days from start of radiation therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.