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Radiation Therapy
Accelerated Radiation for Breast Cancer (ART Trial)
Phase 1 & 2
Waitlist Available
Led By Silvia Formenti, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age older than 18
Pre- or post-menopausal women with Stage I-III breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
ART Trial Summary
This trial is for patients with newly diagnosed breast cancer who need post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Who is the study for?
This trial is for women over 18 with Stage I-III breast cancer who've had neo-adjuvant chemotherapy and surgery. They must understand the study and agree to participate. Excluded are pregnant or breastfeeding women, those with more than 5 affected lymph nodes, previous radiation in the same area, active connective tissue disorders like lupus, or concurrent chemotherapy (except anti HER2neu therapies).Check my eligibility
What is being tested?
The trial tests Accelerated Radiation Therapy (ART) on patients after breast cancer surgery. It aims to see if ART can effectively treat breast cancer by targeting the remaining breast tissue and nearby lymph node areas post-surgery.See study design
What are the potential side effects?
Radiation therapy may cause skin irritation at the treatment site, fatigue, mild swelling in treated areas, changes in skin texture or coloration of the breast, and a slight risk of secondary cancers.
ART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I am a woman with Stage I-III breast cancer, regardless of my menopausal status.
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I had breast surgery and my lymph nodes tested negative for cancer.
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I have had breast surgery after chemotherapy.
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I have completed treatment before surgery to shrink my tumor.
ART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute toxicity will be measured by evaluating the proportion of patients who experience grade II-III dermatitis within 60 days of radiation therapy.
Secondary outcome measures
Proportion of patients with grades 2 or higher toxicity
Quality of life of patients at various time points.
late radiation toxicity in treated patients
Other outcome measures
Distant recurrences will be measured.
local control rates will be measured.
molecular signatures that predict fibrosis will be prospectively measured from blood samples.
+1 moreSide effects data
From 2008 Phase 3 trial • 243 Patients • NCT0021612560%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
54%
LEUKOCYTES (TOTAL WBC)
51%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
48%
DYSPNEA (SHORTNESS OF BREATH)
43%
ESOPHAGITIS
38%
NAUSEA
36%
HEMOGLOBIN
35%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
35%
COUGH
33%
PAIN
32%
ANOREXIA
31%
PAIN - OTHER (SPECIFY, __)
29%
PLATELETS
26%
VOMITING
26%
CONSTIPATION
24%
DIARRHEA
19%
MOOD ALTERATION
18%
NEUROPATHY: SENSORY
18%
INFECTION - OTHER (SPECIFY, __)
18%
WEIGHT LOSS
17%
DIZZINESS
15%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
15%
PNEUMONITIS/PULMONARY INFILTRATES
15%
HEARTBURN/DYSPEPSIA
13%
INSOMNIA
13%
INFECTION - OTHER
12%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
12%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
11%
DEHYDRATION
11%
GASTROINTESTINAL - OTHER (SPECIFY, __)
11%
HYPOTENSION
10%
LYMPHOPENIA
10%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
10%
RASH/DESQUAMATION
10%
RASH: DERMATITIS ASSOCIATED WITH RADIATION
8%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
8%
CARDIAC GENERAL - OTHER (SPECIFY, __)
8%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
7%
ALKALINE PHOSPHATASE
7%
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
7%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
7%
SWEATING (DIAPHORESIS)
7%
SODIUM, SERUM-LOW (HYPONATREMIA)
7%
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
6%
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
6%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
6%
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
6%
AUDITORY/EAR - OTHER (SPECIFY, __)
6%
SYNCOPE (FAINTING)
6%
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
5%
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
5%
HICCOUGHS (HICCUPS, SINGULTUS)
5%
CREATININE
5%
PLEURAL EFFUSION (NON-MALIGNANT)
4%
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
4%
HYPERTENSION
4%
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
4%
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
4%
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
4%
THROMBOSIS/THROMBUS/EMBOLISM
4%
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
4%
RIGORS/CHILLS
4%
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
4%
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
4%
NEUROPATHY: MOTOR
2%
COAGULATION - OTHER (SPECIFY, __)
2%
HYPOXIA
2%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
2%
HEMORRHAGE/BLEEDING - OTHER
2%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
2%
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
2%
PERICARDIAL EFFUSION (NON-MALIGNANT)
2%
BICARBONATE, SERUM-LOW
2%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
2%
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
MEMORY IMPAIRMENT
1%
OCULAR/VISUAL - OTHER (SPECIFY, __)
1%
HOT FLASHES/FLUSHES
1%
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
1%
COLITIS
1%
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
1%
URINARY FREQUENCY/URGENCY
1%
RENAL/GENITOURINARY - OTHER
1%
CARDIAC ARRHYTHMIA - OTHER
1%
CONSTITUTIONAL SYMPTOMS - OTHER
1%
DYSPHAGIA (DIFFICULTY SWALLOWING)
1%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
1%
BLOOD/BONE MARROW - OTHER
1%
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
1%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
1%
VENTRICULAR ARRHYTHMIA
1%
LYMPHATICS - OTHER (SPECIFY, __)
1%
FISTULA, GI
1%
PRURITUS/ITCHING
1%
WATERY EYE (EPIPHORA, TEARING)
1%
SODIUM, SERUM-HIGH (HYPERNATREMIA)
1%
SEIZURE
1%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
1%
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
1%
HEMORRHAGE, GI
1%
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
1%
PHOTOSENSITIVITY
1%
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
1%
WEIGHT GAIN
1%
PAIN - OTHER
1%
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
1%
PULMONARY/UPPER RESPIRATORY - OTHER
1%
ALKALOSIS (METABOLIC OR RESPIRATORY)
1%
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
1%
SYNDROMES - OTHER (SPECIFY, __)
1%
ARTHRITIS (NON-SEPTIC)
1%
BILIRUBIN (HYPERBILIRUBINEMIA)
1%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
1%
INFECTION WITH UNKNOWN ANC
1%
INJECTION SITE REACTION/EXTRAVASATION CHANGES
1%
GASTROINTESTINAL - OTHER
1%
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
1%
HYPOPIGMENTATION
1%
NAIL CHANGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Consolidation Docetaxel
Observation Only
Pre-Randomization
ART Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
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.
Group II: Cohort 1Experimental Treatment1 Intervention
(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
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,454 Total Patients Enrolled
29 Trials studying Breast Cancer
27,142 Patients Enrolled for Breast Cancer
Silvia Formenti, M.D.Principal InvestigatorWeill Cornell Medicine - New York Presbyterian Hospital
13 Previous Clinical Trials
1,245 Total Patients Enrolled
6 Trials studying Breast Cancer
1,068 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymph node removal was incomplete despite cancer presence.I am older than 18 years.I am not on chemotherapy, except for HER2-targeted treatments.I am a woman with Stage I-III breast cancer, regardless of my menopausal status.My breast cancer was removed with clear edges around the tumor.I had breast surgery and my lymph nodes tested negative for cancer.I have had breast surgery after chemotherapy.I have 5 or fewer lymph nodes involved in my cancer.I have completed treatment before surgery to shrink my tumor.I have an active connective tissue disorder like lupus or scleroderma needing treatment for flares.I have had radiation therapy on the same side breast or lymph nodes before.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this clinical study available?
"This research is searching for 74 individuals that have been diagnosed with breast cancer. To participate, patients must be between 19-99 years old and meet the following additional requirements: a) they must provide evidence of their original diagnosis, b) negative margins from their excised tissue sample(s), c) ability to understand and sign an informed consent document, d) those that had neoadjuvant hormonal therapy due to COVID should not exceed 3 months before surgery for clinical T1/T2 BC., e) status post-chemotherapy breast surgery."
Answered by AI
How many people are being signed up for this experiment?
"That is correct. The trial, which began recruitment on August 1st 2016 and was most recently updated on October 11th 2022, is currently seeking 74 patients from 3 hospitals."
Answered by AI
Are geriatric patients being included in this clinical research?
"This clinical trial is seeking patients that fall between the ages of 19 and 99. In contrast, there are 54 other medical studies currently underway for individuals under 18 years old and 1,381 trials for seniors aged 65 and older."
Answered by AI
Are new patients being sought out for this particular clinical trial?
"Yes, according to the clinicaltrials.gov website, this study is still looking for 74 patients from 3 different hospitals or clinics. The trial was first posted on August 1st, 2016 and updated most recently on October 11th, 2020."
Answered by AI
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