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A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive 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: NCT02448771
Recruitment Status : Active, not recruiting
First Posted : May 19, 2015
Results First Posted : July 1, 2021
Last Update Posted : July 1, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rinath Jeselsohn MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer Stage IV
Unresectable Locally Advanced Invasive Breast Cancer
Metastatic Invasive Breast Cancer
Interventions Drug: Palbociclib
Drug: Bazedoxifene
Enrollment 36
Recruitment Details Patients were enrolled between 7/9/2015 and 7/19/2017
Pre-assignment Details  
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Period Title: Overall Study
Started 36
Completed 0
Not Completed 36
Reason Not Completed
Disease Progression             30
Unacceptable Toxicity             1
Physician Decision             3
Started new therapy             2
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
59.5
(37 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
34
  94.4%
Male
2
   5.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Hispanic or Latino
1
   2.8%
Not Hispanic or Latino
31
  86.1%
Unknown or Not Reported
4
  11.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
32
  88.9%
More than one race
1
   2.8%
Unknown or Not Reported
3
   8.3%
ECOG Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
00 - Fully Active
33
  91.7%
01 - Restricted
3
   8.3%
Estrogen Receptor Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Unknown
1
   2.8%
Low Positive
1
   2.8%
Positive (>10% cell staining)
34
  94.4%
Progesterone Receptor Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Unknown
1
   2.8%
Low Positive
1
   2.8%
Positive (>10% cell staining)
22
  61.1%
Negative (<=10% cell staining)
12
  33.3%
Human Epidermal Growth Factor Receptor 2 Amplification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Negative
36
 100.0%
Positive
0
   0.0%
Site of Metastatic Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Lung and Pleural
12
  33.3%
Breast and Chest
14
  38.9%
Lymph Node
13
  36.1%
Liver
23
  63.9%
Bone
26
  72.2%
Others
7
  19.4%
Site of Metastatic Disease: Bone Only  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Yes
2
   5.6%
No
34
  94.4%
Site of Metastatic Disease: Visceral Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Yes
29
  80.6%
No
7
  19.4%
Prior Hormonal Therapy for Metastatic Breast Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Zero
6
  16.7%
One
14
  38.9%
Two
8
  22.2%
Three
6
  16.7%
Four
2
   5.6%
Prior Chemotherapy for Metastatic Breast Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Zero
17
  47.2%
One
16
  44.4%
Two
3
   8.3%
Everolimus for Metastatic Breast Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Yes
4
  11.1%
No
32
  88.9%
Prior Hormonal Therapy for Primary Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Yes
25
  69.4%
No
11
  30.6%
Prior Tamoxifen for Primary or Metastatic Breast Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Yes
26
  72.2%
No
10
  27.8%
1.Primary Outcome
Title Clinical Benefit Rate
Hide Description

Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

SD or better is achieved if the following are true:

Target Lesions:

-At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Non-target Lesions:

  • No progression.
  • No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Bone Lesions:

  • < 25% increase in lesions.
  • No new lesions.
Time Frame Assessed for response for up to 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36
(21 to 56)
2.Primary Outcome
Title Clinical Benefit Rate by ESR1 Genotype
Hide Description

Clinical Benefit Rate is the proportion of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed CR, PR, SD.

SD or better is achieved if the following are true:

Target Lesions:

-At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Non-target Lesions:

  • No progression.
  • No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Bone Lesions:

  • < 25% increase in lesions.
  • No new lesions.

ESR1 genotype determined using established methods

Time Frame Assessed for response for up to 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number analyzed is the sum of both categories (mutant and wild type).
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Wild Type Number Analyzed 16 participants
31
(6.6 to 66)
Mutant Number Analyzed 7 participants
43
(0 to 89)
3.Primary Outcome
Title Percent of Participants With All Grade Neutrophil Count Decrease
Hide Description Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 regardless of whether the event is related or unrelated to treatment. Neutrophil counts are evaluated using established methods.
Time Frame Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Palbociclib

Bazedoxifene

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.1
(45 to 77)
4.Secondary Outcome
Title Number of Participants With All Grade Neutrophil Count Decrease
Hide Description Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 regardless of whether the event is related or unrelated to treatment. Neutrophil counts are evaluated using established methods.
Time Frame Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
22
  61.1%
5.Secondary Outcome
Title Objective Response Rate
Hide Description

The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.

PR or better is achieved if the following are true:

Target Lesions:

-At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Non-target Lesions:

  • No progression.
  • No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Bone Lesions:

->50% increase in lesions.

-No new lesions.

Time Frame Assessed for response for up to 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.1
(3.1 to 26.4)
6.Secondary Outcome
Title Median Progression-Free Survival
Hide Description Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free.
Time Frame Up to 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Rows are representative of subgroups of study population.
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: months
3.58
(1.97 to 7.24)
7.Secondary Outcome
Title Median Overall Survival
Hide Description Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Time Frame Up to 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: months
26.5
(1.5 to 41.5)
8.Secondary Outcome
Title Median Progression-Free Survival for Patients by ESR1 Genotype
Hide Description Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. ESR1 genotype is determined using established methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number analyzed is the sum of both categories (mutant and wild type).
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: months
Mutant Number Analyzed 10 participants
1.92
(1.5 to 23.9)
Wild Type Number Analyzed 17 participants
3.6
(0.9 to 15.2)
9.Secondary Outcome
Title Overall Survival by ESR1 Genotype
Hide Description Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. ESR1 genotype determined by established methods.
Time Frame Up to 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number analyzed is the sum of both categories (mutant and wild type).
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: probability of survival
Wild Type Number Analyzed 16 participants
21.1 [1] 
(13.2 to NA)
Mutant Number Analyzed 7 participants
26.5 [1] 
(1.5 to NA)
[1]
Follow-up is not long enough/data is not mature to provide upper bound confidence interval.
10.Secondary Outcome
Title Objective Response Rate by ESR1 Genotype
Hide Description

The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.

PR or better is achieved if the following are true:

Target Lesions:

-At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Non-target Lesions:

No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Bone Lesions:

->50% increase in lesions.

-No new lesions.

ESR1 genotype determined by established methods.

Time Frame Up to 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number analyzed is the sum of both categories (mutant and wild type).
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description:

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

Palbociclib

Bazedoxifene

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Wild Type Number Analyzed 16 participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
Stable Disease
11
  68.8%
Progressive Disease
5
  31.3%
Mutant Number Analyzed 7 participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
Stable Disease
3
  42.9%
Progressive Disease
4
  57.1%
Time Frame Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months.
Adverse Event Reporting Description Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
 
Arm/Group Title Palbociclib in Combination With Bazedoxifene
Hide Arm/Group Description

Palbociclib 125 mg Oral on days 1-21 per cycle Bazedoxifene 40 mg Oral on days 1-28 per cycle

One cycle is 28 days.

All-Cause Mortality
Palbociclib in Combination With Bazedoxifene
Affected / at Risk (%)
Total   17/36 (47.22%) 
Hide Serious Adverse Events
Palbociclib in Combination With Bazedoxifene
Affected / at Risk (%)
Total   17/36 (47.22%) 
Blood and lymphatic system disorders   
Anemia  1  1/36 (2.78%) 
Infections and infestations   
Bladder infection  1  1/36 (2.78%) 
Bronchial infection  1  1/36 (2.78%) 
Investigations   
Neutrophil count decreased  1  15/36 (41.67%) 
Platelet count decreased  1  1/36 (2.78%) 
White blood cell decreased  1  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/36 (2.78%) 
Vascular disorders   
Thromboembolic event  1  1/36 (2.78%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Palbociclib in Combination With Bazedoxifene
Affected / at Risk (%)
Total   34/36 (94.44%) 
Blood and lymphatic system disorders   
Anemia  1  6/36 (16.67%) 
Blood and lymphatic system disorders - Other, specify  1  1/36 (2.78%) 
Cardiac disorders   
Ventricular arrhythmia  1  1/36 (2.78%) 
Ventricular tachycardia  1  1/36 (2.78%) 
Ear and labyrinth disorders   
Tinnitus  1  1/36 (2.78%) 
Vertigo  1  1/36 (2.78%) 
Eye disorders   
Blurred vision  1  2/36 (5.56%) 
Gastrointestinal disorders   
Abdominal pain  1  1/36 (2.78%) 
Ascites  1  2/36 (5.56%) 
Bloating  1  1/36 (2.78%) 
Constipation  1  7/36 (19.44%) 
Diarrhea  1  7/36 (19.44%) 
Dry mouth  1  1/36 (2.78%) 
Dyspepsia  1  2/36 (5.56%) 
Gastritis  1  1/36 (2.78%) 
Gastroesophageal reflux disease  1  2/36 (5.56%) 
Mucositis oral  1  7/36 (19.44%) 
Nausea  1  12/36 (33.33%) 
Obstruction gastric  1  1/36 (2.78%) 
Stomach pain  1  1/36 (2.78%) 
Vomiting  1  5/36 (13.89%) 
Gastrointestinal disorders - Other, specify  1  1/36 (2.78%) 
General disorders   
Edema limbs  1  2/36 (5.56%) 
Fatigue  1  22/36 (61.11%) 
Fever  1  1/36 (2.78%) 
Flu like symptoms  1  1/36 (2.78%) 
Gait disturbance  1  1/36 (2.78%) 
Non-cardiac chest pain  1  1/36 (2.78%) 
Pain  1  5/36 (13.89%) 
Infections and infestations   
Lung infection  1  1/36 (2.78%) 
Papulopustular rash  1  2/36 (5.56%) 
Rhinitis infective  1  2/36 (5.56%) 
Upper respiratory infection  1  3/36 (8.33%) 
Infections and infestations - Other, specify  1  1/36 (2.78%) 
Injury, poisoning and procedural complications   
Fracture  1  1/36 (2.78%) 
Investigations   
Alanine aminotransferase increased  1  4/36 (11.11%) 
Aspartate aminotransferase increased  1  5/36 (13.89%) 
Electrocardiogram QT corrected interval prolonged  1  1/36 (2.78%) 
Lymphocyte count decreased  1  2/36 (5.56%) 
Neutrophil count decreased  1  21/36 (58.33%) 
Platelet count decreased  1  8/36 (22.22%) 
Weight gain  1  1/36 (2.78%) 
White blood cell decreased  1  3/36 (8.33%) 
Investigations - Other, specify  1  1/36 (2.78%) 
Metabolism and nutrition disorders   
Anorexia  1  4/36 (11.11%) 
Hypercalcemia  1  1/36 (2.78%) 
Hyperglycemia  1  3/36 (8.33%) 
Hypocalcemia  1  1/36 (2.78%) 
Hypokalemia  1  1/36 (2.78%) 
Hyponatremia  1  2/36 (5.56%) 
Hypophosphatemia  1  4/36 (11.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/36 (8.33%) 
Back pain  1  3/36 (8.33%) 
Bone pain  1  1/36 (2.78%) 
Generalized muscle weakness  1  2/36 (5.56%) 
Muscle weakness lower limb  1  1/36 (2.78%) 
Myalgia  1  1/36 (2.78%) 
Neck pain  1  2/36 (5.56%) 
Pain in extremity  1  2/36 (5.56%) 
Musculoskeletal and connective tissue disorder - Other, specify  1  1/36 (2.78%) 
Nervous system disorders   
Dysgeusia  1  1/36 (2.78%) 
Facial nerve disorder  1  1/36 (2.78%) 
Headache  1  5/36 (13.89%) 
Movements involuntary  1  1/36 (2.78%) 
Peripheral motor neuropathy  1  1/36 (2.78%) 
Tremor  1  1/36 (2.78%) 
Vasovagal reaction  1  1/36 (2.78%) 
Nervous system disorders - Other, specify  1  1/36 (2.78%) 
Psychiatric disorders   
Anxiety  1  1/36 (2.78%) 
Delirium  1  1/36 (2.78%) 
Hallucinations  1  1/36 (2.78%) 
Insomnia  1  1/36 (2.78%) 
Psychiatric disorders - Other, specify  1  1/36 (2.78%) 
Renal and urinary disorders   
Hematuria  1  1/36 (2.78%) 
Proteinuria  1  1/36 (2.78%) 
Urinary frequency  1  3/36 (8.33%) 
Urinary urgency  1  1/36 (2.78%) 
Renal and urinary disorders - Other, specify  1  1/36 (2.78%) 
Reproductive system and breast disorders   
Vaginal dryness  1  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/36 (2.78%) 
Cough  1  4/36 (11.11%) 
Dyspnea  1  7/36 (19.44%) 
Epistaxis  1  4/36 (11.11%) 
Postnasal drip  1  2/36 (5.56%) 
Productive cough  1  1/36 (2.78%) 
Pulmonary edema  1  1/36 (2.78%) 
Sore throat  1  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/36 (2.78%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  7/36 (19.44%) 
Dry skin  1  1/36 (2.78%) 
Pruritus  1  2/36 (5.56%) 
Rash acneiform  1  1/36 (2.78%) 
Rash maculo-papular  1  1/36 (2.78%) 
Scalp pain  1  1/36 (2.78%) 
Skin and subcutaneous tissue disorders - Other, specify  1  2/36 (5.56%) 
Vascular disorders   
Hot flashes  1  6/36 (16.67%) 
Superficial thrombophlebitis  1  1/36 (2.78%) 
Thromboembolic event  1  1/36 (2.78%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Rinath Jeselsohn
Organization: Dana-Farber Cancer Institute
Phone: 617.632.6887
EMail: rinath_jeselsohn@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Rinath Jeselsohn MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02448771    
Other Study ID Numbers: 15-060
First Submitted: May 4, 2015
First Posted: May 19, 2015
Results First Submitted: May 6, 2021
Results First Posted: July 1, 2021
Last Update Posted: July 1, 2021