Trial Outcomes & Findings for Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy (NCT NCT02606708)
NCT ID: NCT02606708
Last Updated: 2020-08-14
Results Overview
Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
314 participants
Primary outcome timeframe
5 years
Results posted on
2020-08-14
Participant Flow
Participant milestones
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Overall Study
STARTED
|
314
|
|
Overall Study
COMPLETED
|
314
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy
Baseline characteristics by cohort
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
220 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
314 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Risk rate at 5 years
Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Number of Participants With Local Recurrence in Breast
|
6 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Risk rate at 5 years
Defined by the discovery of invasive disease or DCIS regional recurrence in the lymph node after segmental mastectomy and radiation, by clinical or radiographic means.
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Number of Participants With Regional Recurrence
|
4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Risk rate at 5 years
Defined by the discovery of contra-lateral breast cancer after segmental mastectomy and radiation, by clinical or radio-graphic means.
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Number of Participants With Contralateral Breast Cancer
|
2 Participants
|
PRIMARY outcome
Timeframe: 5 yearsnumber of participants found to have distant metastases after segmental mastectomy and radiation, by clinical or radiographic means
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Number of Participants With Distant Metastases
|
8 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Risk rate at 5 years
Overall 5-Year cumulative rate of death based on Kaplan-Meier Analysis
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Number of Participants With an Outcome of Death
|
17 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Overall, 314 participants were analyzed for each of the below listed toxicities, by grade. The numbers are broken down to toxicity and grade for each row. In total these numbers add to 314
Measure of treatment related late toxicities at or more than 6 months after completion of radiation therapy.
Outcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Maximum Grade Late Radiation Toxicity
Pigmentation Change · Grade 1
|
62 Participants
|
|
Maximum Grade Late Radiation Toxicity
Pigmentation Change · Grade 2
|
2 Participants
|
|
Maximum Grade Late Radiation Toxicity
Pigmentation Change · Grade 3
|
0 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Fibrosis · Grade 1
|
59 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Fibrosis · Grade 2
|
13 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Fibrosis · Grade 3
|
1 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Retraction · Grade 1
|
46 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Retraction · Grade 2
|
17 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Retraction · Grade 3
|
2 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Telangiectasia · Grade 1
|
47 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Telangiectasia · Grade 2
|
19 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Telangiectasia · Grade 3
|
4 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Edema · Grade 1
|
10 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Edema · Grade 2
|
0 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Edema · Grade 3
|
1 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Pain · Grade 1
|
28 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Pain · Grade 2
|
1 Participants
|
|
Maximum Grade Late Radiation Toxicity
Breast Pain · Grade 3
|
0 Participants
|
|
Maximum Grade Late Radiation Toxicity
Arm Lymphadema · Grade 1
|
1 Participants
|
|
Maximum Grade Late Radiation Toxicity
Arm Lymphadema · Grade 2
|
0 Participants
|
|
Maximum Grade Late Radiation Toxicity
Arm Lymphadema · Grade 3
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Patient Self-assessment of the Cosmetic Results
Excellent/Good
|
251 Participants
|
|
Patient Self-assessment of the Cosmetic Results
Fair
|
56 Participants
|
|
Patient Self-assessment of the Cosmetic Results
Poor
|
7 Participants
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 Participants
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Survival
|
94.6 percentage of Patients
|
Adverse Events
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
Serious events: 0 serious events
Other events: 96 other events
Deaths: 17 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
n=314 participants at risk
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
Accelerated intensity modulated radiation therapy (AIMRT)
|
|---|---|
|
Cardiac disorders
Hypertension
|
0.32%
1/314 • 5 Years
|
|
Cardiac disorders
Pericarditis
|
0.64%
2/314 • 5 Years
|
|
General disorders
Fatigue
|
14.6%
46/314 • 5 Years
|
|
Blood and lymphatic system disorders
Hemolitic autoimmune anemia
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
Depression
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN lower extremities
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.32%
1/314 • 5 Years
|
|
Infections and infestations
MASTITIS
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
4/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
RASH BOTH BREASTS
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN Breast Left superior aspect
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Eczema at right inframammary breast
|
0.32%
1/314 • 5 Years
|
|
General disorders
WEIGHT GAIN
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS HANDS AND FEET
|
0.32%
1/314 • 5 Years
|
|
Cardiac disorders
PEDAL EDEMA
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN RIGHT SHOULDER+ LEFT HIP
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
RASH FUNGAL - LEFT AXILLA
|
0.32%
1/314 • 5 Years
|
|
Cardiac disorders
SYNCOPAL EPISODE
|
0.32%
1/314 • 5 Years
|
|
Endocrine disorders
Hot flashes
|
13.4%
42/314 • 5 Years
|
|
Cardiac disorders
RIGHT LEG SURGERY FOR STENT PLACEMENT
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
Pain ARTHRALGIA
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS LEG PAIN
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
MIGRAINE
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN BACK
|
0.32%
1/314 • 5 Years
|
|
Infections and infestations
CELLULITIS RIGHT ARM
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
HAIR THINNING
|
0.32%
1/314 • 5 Years
|
|
Blood and lymphatic system disorders
MELANOMA IN SITU RIGTH LEG
|
0.32%
1/314 • 5 Years
|
|
Endocrine disorders
ADRENAL CORTICAL ADENOMA
|
0.32%
1/314 • 5 Years
|
|
Metabolism and nutrition disorders
ACUTE APPENDICITIS
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE SPONDILOSIS
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN LEFT BREAST AT INCISION SITE sore
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
HEADACHE
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
PRURITIS AT BREAST
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
Pain ARTHRALGIA GENERALIZED
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
DIZZINESS
|
0.32%
1/314 • 5 Years
|
|
Gastrointestinal disorders
NAUSEA
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN AXILLA BOTH
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN LEFT SHOULDER
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
ARTHRALGIA
|
0.32%
1/314 • 5 Years
|
|
Hepatobiliary disorders
INCREASED LIVER ENZYMES
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
FRACTURE 2ND LEFT RIB
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN RIGHT THIGH
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
NUMBNESS
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN LEFT BREAST
|
0.32%
1/314 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second Malignancy Invasive ductal ca
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
LEFT FRACTURE ARM LEFT
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN BREAST
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN BACK LOWER
|
0.32%
1/314 • 5 Years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.32%
1/314 • 5 Years
|
|
Immune system disorders
LYMPHEDEMA ARM LEFT
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
MENINGIOMA
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Secondary malignancySKIN CANCER (LEG)
|
0.32%
1/314 • 5 Years
|
|
Endocrine disorders
NIGHT SWEATS
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
MEMORY LOSS/UNSTEADINESS (DUE TO MENINGIOMA)
|
0.32%
1/314 • 5 Years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
SEBORRHOIC KERATOSIS UNDER RIGHT BREAST
|
0.32%
1/314 • 5 Years
|
|
Endocrine disorders
PAIN BONE
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN BONE
|
0.32%
1/314 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second Malignancy NEW PRIMARY AT LEFT BREAST
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN ARM LEFT
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
MYALGIA
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN SCAR
|
0.32%
1/314 • 5 Years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.32%
1/314 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second Malignancy RIGHT ANKLE MELANOMA
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS, CARPAL TUNNEL SYNDROME
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN Arthralgia KNEE B/L
|
0.32%
1/314 • 5 Years
|
|
General disorders
WEIGHT LOSS
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PARESTHESIA ARM LEFT
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
Pain ARTHRALGIA - Occasional
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN RIGHT RIB AREA
|
0.32%
1/314 • 5 Years
|
|
Cardiac disorders
Cardiovascular / General Other: SPLENIC HEMANGIOMA
|
0.32%
1/314 • 5 Years
|
|
General disorders
HAIR THINNING
|
0.32%
1/314 • 5 Years
|
|
Nervous system disorders
PAIN RIGHT THUMB severe
|
0.32%
1/314 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS RIGHT WRIST
|
0.32%
1/314 • 5 Years
|
Additional Information
Carmen Perez, MD
New York University School of Medicine
Phone: 212 731 5003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place