Trial Outcomes & Findings for Study of Prone Accelerated Breast And Nodal IMRT (NCT NCT02308488)
NCT ID: NCT02308488
Last Updated: 2023-04-27
Results Overview
"Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details. Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
Day 60
Results posted on
2023-04-27
Participant Flow
Participant milestones
| Measure |
Radiation Therapy
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Radiation Therapy
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Study of Prone Accelerated Breast And Nodal IMRT
Baseline characteristics by cohort
| Measure |
Radiation Therapy
n=95 Participants
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
|
Age, Continuous
|
57.02 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 60"Toxicity Grading per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 3.0). Please refer to the Protocol Appendix 1 for details. Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death"
Outcome measures
| Measure |
Radiation Therapy
n=95 Participants
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 60Treatment feasibility will be evaluated for each participant by the ability to meet all physics dose constraints: Target volume dose constraints = PTVTumor: V 48 Gy \> 98%, PTVBreast: V 40.5 Gy ≥ 95%. PTVNodesEval: V 38.5 Gy \> 95%. Normal tissue dose constraints = Heart: V 5 Gy \< 5%, Ipsilateral lung: V 10 Gy \< 20%, Contralateral lung: V 5 Gy \< 15%, Spinal cord: 37.5 Gy maximum, Spinal cord plus 0.5 cm margin: 40 Gy maximum, Thyroid: contralateral lobe 15 Gy maximum, Esophagus: V 30 Gy \< 50%, 40.5 Gy maximum, Ipsilateral brachial plexus: 42 Gy maximum, Contralateral breast: Efforts should be made to keep the contralateral breast completely outside the primary beams
Outcome measures
| Measure |
Radiation Therapy
n=95 Participants
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Number of Participants Who Met Constraints
|
95 Participants
|
Adverse Events
Radiation Therapy
Serious events: 1 serious events
Other events: 87 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Radiation Therapy
n=95 participants at risk
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Infections and infestations
Cellulitis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
Other adverse events
| Measure |
Radiation Therapy
n=95 participants at risk
Intensity-modulated radiation therapy (IMRT): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Bloating
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Investigations
Alkaline phosphatase increased
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Altered Mental Status
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Anorexia
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Psychiatric disorders
Anxiety
|
6.3%
6/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.8%
35/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Investigations
AST elevated
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Atrophy/Symmetry
|
32.6%
31/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Immune system disorders
Autoimmune Thyroiditis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Metastasis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Breast Heaviness
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Breast Pain
|
27.4%
26/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Bruising on shin
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Injury, poisoning and procedural complications
Grease Burn
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Renal and urinary disorders
Burning urination
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Infections and infestations
Cellulitis
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Cardiac disorders
Chest Pain / Tightness
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukemia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
7/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Metabolism and nutrition disorders
Creatinine Elevated
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst, Upper Back
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cysts, Thyroid
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DCIS, Left (Contralateral) Breast
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Decreased Libido
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Decreased ROM
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Eye disorders
Decreased Vision
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Psychiatric disorders
Depression
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Dimpling
|
9.5%
9/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Diverticulosis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Dry Desquamation
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Dysgeusia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Edema
|
13.7%
13/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Erythema / Dermatitis
|
60.0%
57/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Esophagitis
|
14.7%
14/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Eye disorders
Eye Dryness, Left
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Eye disorders
Eyelid Function Disorder
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Fat Necrosis
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Fatigue
|
74.7%
71/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Fever
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Fibrosis
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Flu Like Sympotms
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Generalized Pain
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Globus Sensation In Throat
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
Goiter
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Headache
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Hematochezia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Hemorroids
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
Hot Flashes
|
60.0%
57/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
Hyperglycemia
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Investigations
Hypernatremia
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
18.9%
18/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Cardiac disorders
Hypertension
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Induration
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Infections and infestations
Infection
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Injury, poisoning and procedural complications
Injury (Tore Cartilage)
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Injury, poisoning and procedural complications
Injury-Torn Meniscus Right Knee
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Insomnia
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Irritability
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Keratosis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Left Lung Post Radiation changes
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Leg Spasms
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leptomeningeal Disease/ Brain Mets
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Lower Flank Pain
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Blood and lymphatic system disorders
Lymphadema
|
10.5%
10/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Infections and infestations
Mastitis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Memory Impairment
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Moist Desquamation
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
8/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Neuropathy
|
14.7%
14/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
Night Sweats
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Nipple Discharge Left Breast
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Nipple Inversion
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Nipple Sensitivity
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Nipple, skin fissure
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Odynophagia
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Infections and infestations
Onychomycosis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Pain
|
9.5%
9/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Psychiatric disorders
Panic Attack-Agoraphobia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Paresthesia
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture R Proximal Femur
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion, Requiring Vats
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
17/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Radiation Folliculitis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.6%
11/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Right Rib Pain On Inspiration And When Coughing
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Nervous system disorders
Sensitivity To Cold, Fingers/Toes
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seroma
|
7.4%
7/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Disfunction
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Skin and subcutaneous tissue disorders
Skin Thickening
|
14.7%
14/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Sore Throat
|
5.3%
5/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Blood and lymphatic system disorders
Telangiectasia
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Infections and infestations
Thrush
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Endocrine disorders
TSH, Elevated
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Tuberculosis
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
2.1%
2/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Renal and urinary disorders
Urinary Retention
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
3.2%
3/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Uterine Toxicity/Bleeding
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Vaginal Atrophy/Irritation
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
4.2%
4/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Weight Gain
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
|
General disorders
Weight Loss
|
1.1%
1/95 • 5 years from the first day of treatment
Adverse Events are collected throughout the study period via physical exams, lab assessments as well as patient communications.
|
Additional Information
Carmen A. Perez, M.D., Ph.D.
NYU Langone Health - Perlmutter Cancer Center
Phone: 212-731-5003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place