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Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633331
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor-positive Breast Cancer
HER2/Neu Negative
Stage IV Breast Cancer AJCC v6 and v7
Interventions Drug: Palbociclib
Drug: Letrozole
Drug: Fulvestrant
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Palbociclib, Letrozole or Fulvestrant)
Hide Arm/Group Description

Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>

> Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
Started 93
Completed 92
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Palbociclib, Letrozole or Fulvestrant)
Hide Arm/Group Description

Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>

> Quality-of-Life Assessment: Ancillary studies
Overall Number of Baseline Participants 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 93 participants
74
(70 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Female
92
  98.9%
Male
1
   1.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Hispanic or Latino
3
   3.2%
Not Hispanic or Latino
88
  94.6%
Unknown or Not Reported
2
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   4.3%
White
85
  91.4%
More than one race
0
   0.0%
Unknown or Not Reported
3
   3.2%
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
patients meeting the eligibility criteria who have not withdrawn before treatment and have adverse event data available are considered evaluable for the primary endpoint.
Arm/Group Title Treatment (Palbociclib, Letrozole or Fulvestrant)
Hide Arm/Group Description:

Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies>

> Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.756
(0.654 to 0.840)
2.Secondary Outcome
Title Incidence of Drug Toxicities - Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0
Hide Description Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0
Time Frame Up to 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Dose Reduction, Dose Hold, and Hospitalization Reasons
Hide Description A 95% binomial confidence interval for single proportions will be constructed for the percentage of patients that had at least one dose reduction, dose hold, or hospitalization within the first year of treatment.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression)
Hide Description Distributions time to treatment failure will be estimated using Kaplan-Meier methodology. Treatment failure is defined as a severe adverse event, disease progression or patient refusal to continue assigned treatment. Any reason that treatment is discontinued to time to treatment failure and not censor patients will be included. The reason for treatment discontinuation will be captured.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Palbociclib Adherence Rate
Hide Description Patients to be included in the analysis cohort will be those patients who have taken one or more doses of the study treatment. Those patients will be considered adherent to study treatment. For each of the first 3 cycles, an estimate of the proportion of patients who meet the criteria for adherence and its corresponding 95% confidence interval will be determined.
Time Frame Up to 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description The response rate is defined as the proportion of patients whose disease status met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart. A 95% binomial confidence interval for the response rate will be constructed.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Distributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology.
Time Frame From start of treatment to the first of the following disease events: local/regional/distant recurrence, invasive contralateral breast disease, second primary or death due to any cause, assessed up to 5 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description Distributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Overall Treatment Utility (OTU) Results
Hide Description OTU is a novel composite endpoint developed by investigators of the FOCUS2 trial to assess the outcome of palliative chemotherapy. The patient will be given either an overall score of "good", "intermediate", or "poor". A 95% binomial confidence interval will be constructed for the percentage of patients that scored "good" on the OTU.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Sarcopenia Analysis
Hide Description Will examine variables associated with skeletal muscle loss during treatment and whether skeletal muscle loss during treatment is associated with the presence of grade 3-5 toxicity and adverse events. Sarcopenia will be treated as a binary variable using the Skeletal Muscle Index (SMI) (SMI < 41 cm^2/m^2 vs. SMI > 41 cm^2/m^2) and differences in grades chemotherapy toxicity and adverse events will be analyzed using two group t-tests and fisher's exact test. The number of patients with and without sarcopenia grouped by patients with or without grade 3+ Adverse Events (AE's) will be also be reported.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L)
Hide Description European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) is comprised of 5 dimensions. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, no problems, some problems, extreme problems. The EQ-5D-3L can be converted to a single summary index. The median and range of this total score will be reported.
Time Frame Up to 1 year
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Palbociclib, Letrozole or Fulvestrant)
Hide Arm/Group Description Quality-of-Life Assessment: Ancillary studies
All-Cause Mortality
Treatment (Palbociclib, Letrozole or Fulvestrant)
Affected / at Risk (%)
Total   4/92 (4.35%)    
Hide Serious Adverse Events
Treatment (Palbociclib, Letrozole or Fulvestrant)
Affected / at Risk (%) # Events
Total   35/92 (38.04%)    
Blood and lymphatic system disorders   
Anemia † 1  6/92 (6.52%)  19
Febrile neutropenia † 1  1/92 (1.09%)  1
Cardiac disorders   
Cardiac arrest † 1  1/92 (1.09%)  2
Eye disorders   
Eye disorders - Other, specify † 1  1/92 (1.09%)  1
Gastrointestinal disorders   
Abdominal pain † 1  2/92 (2.17%)  2
Ascites † 1  1/92 (1.09%)  1
Diarrhea † 1  2/92 (2.17%)  8
Dysphagia † 1  1/92 (1.09%)  1
Enterocolitis † 1  1/92 (1.09%)  1
Gastric hemorrhage † 1  1/92 (1.09%)  5
Mucositis oral † 1  2/92 (2.17%)  3
Nausea † 1  5/92 (5.43%)  7
Vomiting † 1  2/92 (2.17%)  2
General disorders   
Chills † 1  1/92 (1.09%)  2
Death NOS † 1  1/92 (1.09%)  1
Fatigue † 1  6/92 (6.52%)  10
Fever † 1  1/92 (1.09%)  1
Flu like symptoms † 1  1/92 (1.09%)  1
Gen disord and admin site conds-Oth spec † 1  1/92 (1.09%)  1
Non-cardiac chest pain † 1  2/92 (2.17%)  5
Hepatobiliary disorders   
Hepatic failure † 1  1/92 (1.09%)  1
Immune system disorders   
Allergic reaction † 1  1/92 (1.09%)  1
Infections and infestations   
Lung infection † 1  1/92 (1.09%)  1
Sepsis † 1  1/92 (1.09%)  1
Upper respiratory infection † 1  1/92 (1.09%)  1
Urinary tract infection † 1  1/92 (1.09%)  1
Injury, poisoning and procedural complications   
Hip fracture † 1  1/92 (1.09%)  1
Investigations   
Alanine aminotransferase increased † 1  1/92 (1.09%)  1
Aspartate aminotransferase increased † 1  1/92 (1.09%)  1
Creatinine increased † 1  1/92 (1.09%)  2
Neutrophil count decreased † 1  10/92 (10.87%)  25
Platelet count decreased † 1  3/92 (3.26%)  7
White blood cell decreased † 1  8/92 (8.70%)  19
Metabolism and nutrition disorders   
Anorexia † 1  1/92 (1.09%)  4
Hyperglycemia † 1  1/92 (1.09%)  1
Hyperphosphatemia † 1  1/92 (1.09%)  1
Hypoalbuminemia † 1  1/92 (1.09%)  1
Hypocalcemia † 1  1/92 (1.09%)  2
Hypokalemia † 1  1/92 (1.09%)  1
Hypophosphatemia † 1  1/92 (1.09%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  1/92 (1.09%)  2
Back pain † 1  2/92 (2.17%)  2
Generalized muscle weakness † 1  3/92 (3.26%)  3
Muscle cramp † 1  1/92 (1.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, mal, uncpec - Oth spec † 1  1/92 (1.09%)  1
Nervous system disorders   
Peripheral motor neuropathy † 1  1/92 (1.09%)  1
Peripheral sensory neuropathy † 1  1/92 (1.09%)  4
Stroke † 1  1/92 (1.09%)  1
Psychiatric disorders   
Confusion † 1  1/92 (1.09%)  1
Insomnia † 1  1/92 (1.09%)  1
Renal and urinary disorders   
Acute kidney injury † 1  1/92 (1.09%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea † 1  5/92 (5.43%)  6
Hypoxia † 1  1/92 (1.09%)  1
Pleural effusion † 1  1/92 (1.09%)  1
Pneumothorax † 1  1/92 (1.09%)  1
Productive cough † 1  1/92 (1.09%)  1
Resp, thoracic, mediastinal - Oth spec † 1  1/92 (1.09%)  1
Respiratory failure † 1  1/92 (1.09%)  1
Skin and subcutaneous tissue disorders   
Dry skin † 1  1/92 (1.09%)  2
Surgical and medical procedures   
Surgical and medical proced - Oth spec † 1  1/92 (1.09%)  1
Vascular disorders   
Hot flashes † 1  1/92 (1.09%)  2
Hypertension † 1  2/92 (2.17%)  3
Thromboembolic event † 1  1/92 (1.09%)  1
1
Term from vocabulary, MedDRA 12
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Palbociclib, Letrozole or Fulvestrant)
Affected / at Risk (%) # Events
Total   92/92 (100.00%)    
Blood and lymphatic system disorders   
Anemia † 1  72/92 (78.26%)  549
Blood and lymph sys disorders - Oth Spec † 1  3/92 (3.26%)  39
Febrile neutropenia † 1  2/92 (2.17%)  2
Cardiac disorders   
Atrial fibrillation † 1  2/92 (2.17%)  19
Cardiac disorders - Other, specify † 1  3/92 (3.26%)  3
Chest pain - cardiac † 1  3/92 (3.26%)  13
Heart failure † 1  1/92 (1.09%)  20
Mobitz (type) II atrioventricular block † 1  1/92 (1.09%)  1
Palpitations † 1  1/92 (1.09%)  2
Sinus bradycardia † 1  2/92 (2.17%)  2
Ear and labyrinth disorders   
Ear pain † 1  1/92 (1.09%)  4
Hearing impaired † 1  2/92 (2.17%)  5
Vertigo † 1  2/92 (2.17%)  5
Endocrine disorders   
Endocrine disorders - Other, specify † 1  1/92 (1.09%)  1
Hypothyroidism † 1  3/92 (3.26%)  44
Eye disorders   
Blurred vision † 1  6/92 (6.52%)  54
Cataract † 1  2/92 (2.17%)  17
Dry eye † 1  3/92 (3.26%)  5
Eye disorders - Other, specify † 1  3/92 (3.26%)  8
Eye pain † 1  1/92 (1.09%)  2
Watering eyes † 1  2/92 (2.17%)  22
Gastrointestinal disorders   
Abdominal distension † 1  1/92 (1.09%)  6
Abdominal pain † 1  3/92 (3.26%)  9
Bloating † 1  2/92 (2.17%)  3
Cheilitis † 1  1/92 (1.09%)  1
Colitis † 1  1/92 (1.09%)  1
Constipation † 1  17/92 (18.48%)  63
Dental caries † 1  1/92 (1.09%)  1
Diarrhea † 1  40/92 (43.48%)  214
Dry mouth † 1  10/92 (10.87%)  53
Dyspepsia † 1  7/92 (7.61%)  39
Dysphagia † 1  4/92 (4.35%)  16
Esophageal pain † 1  1/92 (1.09%)  1
Fecal incontinence † 1  2/92 (2.17%)  10
Flatulence † 1  1/92 (1.09%)  1
Gastroesophageal reflux disease † 1  9/92 (9.78%)  35
Gastrointestinal disorders - Oth spec † 1  3/92 (3.26%)  3
Mucositis oral † 1  30/92 (32.61%)  135
Nausea † 1  40/92 (43.48%)  153
Oral hemorrhage † 1  1/92 (1.09%)  1
Oral pain † 1  2/92 (2.17%)  2
Rectal pain † 1  1/92 (1.09%)  1
Toothache † 1  1/92 (1.09%)  2
Vomiting † 1  14/92 (15.22%)  25
General disorders   
Chills † 1  6/92 (6.52%)  8
Edema face † 1  1/92 (1.09%)  1
Edema limbs † 1  8/92 (8.70%)  32
Fatigue † 1  78/92 (84.78%)  716
Fever † 1  4/92 (4.35%)  5
Flu like symptoms † 1  1/92 (1.09%)  1
Gait disturbance † 1  2/92 (2.17%)  6
Gen disord and admin site conds-Oth spec † 1  1/92 (1.09%)  1
Injection site reaction † 1  3/92 (3.26%)  10
Localized edema † 1  1/92 (1.09%)  7
Malaise † 1  1/92 (1.09%)  1
Non-cardiac chest pain † 1  1/92 (1.09%)  9
Pain † 1  19/92 (20.65%)  44
Immune system disorders   
Allergic reaction † 1  1/92 (1.09%)  1
Infections and infestations   
Bone infection † 1  1/92 (1.09%)  4
Bronchial infection † 1  1/92 (1.09%)  1
Eye infection † 1  1/92 (1.09%)  1
Infections and infestations - Oth spec † 1  3/92 (3.26%)  3
Lip infection † 1  1/92 (1.09%)  7
Mucosal infection † 1  1/92 (1.09%)  16
Otitis externa † 1  1/92 (1.09%)  4
Otitis media † 1  1/92 (1.09%)  1
Papulopustular rash † 1  1/92 (1.09%)  1
Sepsis † 1  1/92 (1.09%)  1
Sinusitis † 1  2/92 (2.17%)  4
Skin infection † 1  2/92 (2.17%)  4
Tooth infection † 1  1/92 (1.09%)  1
Upper respiratory infection † 1  9/92 (9.78%)  10
Urinary tract infection † 1  7/92 (7.61%)  8
Wound infection † 1  1/92 (1.09%)  3
Injury, poisoning and procedural complications   
Bruising † 1  5/92 (5.43%)  11
Burn † 1  1/92 (1.09%)  2
Dermatitis radiation † 1  2/92 (2.17%)  2
Fall † 1  6/92 (6.52%)  6
Fracture † 1  4/92 (4.35%)  4
Spinal fracture † 1  1/92 (1.09%)  2
Investigations   
Alanine aminotransferase increased † 1  14/92 (15.22%)  49
Alkaline phosphatase increased † 1  7/92 (7.61%)  29
Aspartate aminotransferase increased † 1  12/92 (13.04%)  45
Blood bilirubin increased † 1  1/92 (1.09%)  6
Blood lactate dehydrogenase increased † 1  1/92 (1.09%)  14
CD4 lymphocytes decreased † 1  1/92 (1.09%)  1
Cholesterol high † 1  1/92 (1.09%)  1
Creatinine increased † 1  20/92 (21.74%)  66
Investigations - Other, specify † 1  4/92 (4.35%)  15
Lymphocyte count decreased † 1  26/92 (28.26%)  96
Neutrophil count decreased † 1  85/92 (92.39%)  885
Platelet count decreased † 1  61/92 (66.30%)  379
Weight gain † 1  1/92 (1.09%)  6
Weight loss † 1  4/92 (4.35%)  10
White blood cell decreased † 1  80/92 (86.96%)  897
Metabolism and nutrition disorders   
Anorexia † 1  28/92 (30.43%)  96
Dehydration † 1  4/92 (4.35%)  5
Glucose intolerance † 1  1/92 (1.09%)  6
Hypercalcemia † 1  4/92 (4.35%)  15
Hyperglycemia † 1  22/92 (23.91%)  104
Hyperkalemia † 1  1/92 (1.09%)  5
Hyperlipidemia † 1  2/92 (2.17%)  38
Hypernatremia † 1  2/92 (2.17%)  4
Hyperphosphatemia † 1  2/92 (2.17%)  2
Hypertriglyceridemia † 1  1/92 (1.09%)  6
Hypoalbuminemia † 1  6/92 (6.52%)  15
Hypocalcemia † 1  11/92 (11.96%)  25
Hypoglycemia † 1  2/92 (2.17%)  2
Hypokalemia † 1  6/92 (6.52%)  15
Hypomagnesemia † 1  2/92 (2.17%)  8
Hyponatremia † 1  7/92 (7.61%)  22
Hypophosphatemia † 1  2/92 (2.17%)  2
Metabolism, nutrition disord - Oth spec † 1  1/92 (1.09%)  1
Obesity † 1  1/92 (1.09%)  17
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  21/92 (22.83%)  107
Arthritis † 1  1/92 (1.09%)  17
Back pain † 1  24/92 (26.09%)  129
Bone pain † 1  6/92 (6.52%)  31
Buttock pain † 1  1/92 (1.09%)  1
Chest wall pain † 1  2/92 (2.17%)  6
Generalized muscle weakness † 1  8/92 (8.70%)  19
Joint range of motion decreased † 1  1/92 (1.09%)  5
Muscle cramp † 1  3/92 (3.26%)  11
Muscle weakness lower limb † 1  1/92 (1.09%)  1
Musculoskeletal, conn tissue - Oth spec † 1  2/92 (2.17%)  3
Myalgia † 1  12/92 (13.04%)  43
Neck pain † 1  3/92 (3.26%)  7
Osteoporosis † 1  1/92 (1.09%)  17
Pain in extremity † 1  16/92 (17.39%)  59
Nervous system disorders   
Ataxia † 1  1/92 (1.09%)  7
Cognitive disturbance † 1  1/92 (1.09%)  8
Dizziness † 1  7/92 (7.61%)  12
Dysgeusia † 1  8/92 (8.70%)  21
Headache † 1  9/92 (9.78%)  16
Memory impairment † 1  3/92 (3.26%)  15
Nervous system disorders - Oth spec † 1  2/92 (2.17%)  2
Neuralgia † 1  1/92 (1.09%)  15
Peripheral motor neuropathy † 1  2/92 (2.17%)  6
Peripheral sensory neuropathy † 1  36/92 (39.13%)  315
Tremor † 1  3/92 (3.26%)  10
Vasovagal reaction † 1  1/92 (1.09%)  1
Psychiatric disorders   
Agitation † 1  1/92 (1.09%)  16
Anxiety † 1  7/92 (7.61%)  20
Confusion † 1  3/92 (3.26%)  6
Depression † 1  10/92 (10.87%)  15
Insomnia † 1  13/92 (14.13%)  72
Irritability † 1  1/92 (1.09%)  1
Personality change † 1  1/92 (1.09%)  3
Renal and urinary disorders   
Chronic kidney disease † 1  3/92 (3.26%)  27
Dysuria (painful urination) † 1  1/92 (1.09%)  5
Glucosuria † 1  1/92 (1.09%)  1
Hematuria † 1  2/92 (2.17%)  2
Renal and urinary disorders - Oth spec † 1  4/92 (4.35%)  5
Urinary frequency † 1  3/92 (3.26%)  15
Urinary incontinence † 1  2/92 (2.17%)  2
Urinary retention † 1  1/92 (1.09%)  1
Urinary tract obstruction † 1  1/92 (1.09%)  1
Reproductive system and breast disorders   
Breast pain † 1  1/92 (1.09%)  1
Pelvic pain † 1  2/92 (2.17%)  6
Vaginal discharge † 1  1/92 (1.09%)  2
Vaginal dryness † 1  1/92 (1.09%)  8
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis † 1  3/92 (3.26%)  20
Cough † 1  12/92 (13.04%)  37
Dyspnea † 1  15/92 (16.30%)  73
Hiccups † 1  2/92 (2.17%)  8
Hypoxia † 1  1/92 (1.09%)  1
Nasal congestion † 1  1/92 (1.09%)  1
Pleural effusion † 1  1/92 (1.09%)  1
Postnasal drip † 1  1/92 (1.09%)  1
Productive cough † 1  1/92 (1.09%)  1
Rhinorrhea † 1  1/92 (1.09%)  1
Voice alteration † 1  1/92 (1.09%)  2
Wheezing † 1  1/92 (1.09%)  1
Skin and subcutaneous tissue disorders   
Alopecia † 1  27/92 (29.35%)  102
Dry skin † 1  14/92 (15.22%)  58
Hyperhidrosis † 1  2/92 (2.17%)  16
Nail changes † 1  3/92 (3.26%)  8
Nail ridging † 1  1/92 (1.09%)  18
Palmar-plantar erythrodysesthesia syndrm † 1  1/92 (1.09%)  2
Pruritus † 1  7/92 (7.61%)  13
Rash acneiform † 1  1/92 (1.09%)  1
Rash maculo-papular † 1  4/92 (4.35%)  8
Skin and subcut tissue disord - Oth spec † 1  2/92 (2.17%)  3
Surgical and medical procedures   
Surgical and medical proced - Oth spec † 1  2/92 (2.17%)  3
Vascular disorders   
Hot flashes † 1  17/92 (18.48%)  92
Hypertension † 1  21/92 (22.83%)  138
Hypotension † 1  3/92 (3.26%)  12
Lymphedema † 1  7/92 (7.61%)  37
Thromboembolic event † 1  5/92 (5.43%)  13
Vascular disorders - Other, specify † 1  2/92 (2.17%)  2
1
Term from vocabulary, MedDRA 12
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mina S. Sedrak MD, MS
Organization: City of Hope Comprehensive Cancer Center
Phone: 626-218-4173
EMail: msedrak@coh.org
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03633331    
Other Study ID Numbers: A171601
NCI-2017-01596 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Submitted: August 7, 2018
First Posted: August 16, 2018
Results First Submitted: September 17, 2021
Results First Posted: October 15, 2021
Last Update Posted: October 15, 2021