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Cabergoline in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01730729
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Lynn Sage Foundation
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Breast Cancer
Stage IV Breast Cancer
Intervention Drug: cabergoline
Enrollment 20
Recruitment Details The study opened for accrual on November 29, 2012 with an accrual goal of up to 20 patients. The first patient starting treatment February 11, 2013. Accrual was suspended twice during the study; May 28 2014 reopening June 11, 2014 and July 24 2015, reopening August 27 2015. The study was closed October 21, 2015 with 20 patients enrolled.
Pre-assignment Details  
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Period Title: Overall Study
Started 20
Completed 2 Cycles/Reached 1st Response 18
Treated Cycle 3 and Beyond 6
Completed [1] 6
Not Completed 14
Reason Not Completed
Adverse Event             1
Death             1
Progressive Disease             12
[1]
Patients treated until progressive disease, unacceptable toxicity, or withdrawal from study
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Baseline Participants 20
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  60.0%
>=65 years
8
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
1
   5.0%
Asian
3
  15.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Overall Response Rate (ORR) at 2 Months
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Overall Response Rate (ORR) is defined as the number of patients that achieved Complete Response (CR) or Partial Response (PR) and will be assessed after 8 weeks (2 cycles) of therapy using CT scan images and RECIST guidelines.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.

Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Time Frame After 8 weeks (2 cycles) of treament
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Hide Analysis Population Description
2 patients did not reach 8 week response time point and were determined not to be evaluable for this objective.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression Free Survival (PFS) will be measured from time of treatment initiation until first documentation of progression of disease or death from any cause.
Time Frame From start of treatment until progression of disease or death
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[Not Specified]
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
1.84
(1.84 to 3.68)
3.Secondary Outcome
Title Treatment Toxicity
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Toxicity will be assessed at the beginning of each cycle (1 cycle equals 28 days) during treatment and 30 days post last treatment during treatment. Toxicity will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Grades 1 through 4 adverse events that were determined to be at least possibly related to treatment are combined and reported below.

Time Frame After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment
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[Not Specified]
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Nausea 6
Fatigue 5
Hyponatremia 3
Alkaline Phosphatase increased 3
Aspartate Aminotansferase increased 2
Hyperglycemia 2
Hypokalemia 2
Vomiting 1
Pain in extremity 1
Acute Kidney Injury 1
Alanine Aminotranserase increased 1
Arthralgia 1
Creatinine increased 1
Diarrhea 1
Dizziness 1
Dry eye 1
Hyperkalemia 1
Hypernatremia 1
Hypocalcemia 1
Hypoglycemia 1
Insomnia 1
Pain 1
White Blood Cell decreased 1
4.Secondary Outcome
Title Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles
Hide Description At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.
Time Frame At baseline and at 8 weeks
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Hide Analysis Population Description
This data was not collected and analysed as it was decided that it was not meaningful on its own.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle
Hide Description Evaluate prolactin expression in biopsy tissue taken at baseline and after 4 weeks (1 cycle) of treatment.
Time Frame At baseline and after 4 weeks (1 cycle)
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Hide Analysis Population Description
No data collected as no patients completed repeat biopsy after 1 cycle of treatment.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Correlate Tissue Prolactin Biomarkers With Response to Therapy
Hide Description Baseline tumor tissue was analyzed for prolactin receptor (PRLr) expression and was provided with an IHC-based Allred score of 0 to 300 based on percentage intensity where lower scores indicate less PRLr expression and high scores indicate more PRLr expression. Only the malignant epithelium was scored. The score was correlated with best response of patient.
Time Frame At baseline
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Hide Analysis Population Description
Only 9 patients had sufficient baseline tissue to be analyzed.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: score on a scale
Stable Disease Number Analyzed 3 participants
170
(110 to 220)
Progressive Disease Number Analyzed 6 participants
220
(120 to 250)
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) is defined from the first day of treatment until death from any cause.
Time Frame From the start of treatment until death from any cause. Median follow up time of 6.817 months (95%CI 0.22-26.18)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
10.41 [1] 
(7.06 to NA)
[1]
At the time of data collection cut off, not all patients were deceased and upper CI was not calculated.
8.Post-Hoc Outcome
Title Clinical Benefit Rate (CBR) After 2 Cycles of Treatment
Hide Description

Clinical Benefit Rate (CBR) is defined as the number of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and is assessed by RECIST guidelines for measurements of CT scan at 8 weeks (2 cycles) of treatment.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.

Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Time Frame After 8 weeks (2 cycles) of treatment
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Hide Analysis Population Description
2 patients did not reach the 8 week response assessment time point.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  33.3%
9.Post-Hoc Outcome
Title Disease Control at 12 Months
Hide Description Number of patients without progressive disease as assessed by CT scan and RECIST guidelines at 12 months of treatment.
Time Frame At 12 months from start of treatment
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[Not Specified]
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
10.Post-Hoc Outcome
Title Best Overall Response
Hide Description

Best Overall Response is defined as patients best response to treatment from treatment initiation until the end of treatment as assessed by RECIST guidelines of CT scans.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.

Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Time Frame From the start of treatment until the end of treatment up to a maximum of 20 cycles (1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient died on treatment 7 days after starting and was not included in this outcome measure.
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
   5.3%
Stable Disease
5
  26.3%
Progressive Disease
13
  68.4%
11.Post-Hoc Outcome
Title Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment
Hide Description Serum prolactin measurements were taken at baseline and after completion of two cycles of treatment. The mean drop was calculated for all patients, and for patients with best response of Stable Disease and Progressive Disease.
Time Frame At baseline and after 2 cycles of treatment where 1 cycle =4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Serum prolactin at baseline and after 2 cycles of treatment were only available for 12 patients.
Arm/Group Title Treatment (Cabergoline)
Hide Arm/Group Description:

Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: ng/ml
All Number Analyzed 12 participants
-9.425
(-36.70 to -0.50)
Stable Disease Number Analyzed 5 participants
-8.72
(-11.50 to -5.50)
Progressive Disease Number Analyzed 12 participants
-9.93
(-36.70 to -0.50)
Time Frame Adverse events were collected over a 3 year period for the whole study. Patients were followed from treatment initiation, throughout treatment and 30 days post last treatment for up to 20 cycles (max number of cycles that any patient was treated) where 1 cycle equals 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Cabergoline)
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Patients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

cabergoline: Given orally

All-Cause Mortality
Treatment (Cabergoline)
Affected / at Risk (%)
Total   12/20 (60.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Cabergoline)
Affected / at Risk (%) # Events
Total   4/20 (20.00%)    
General disorders   
Death NOS  1  1/20 (5.00%)  1
Pain  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/20 (10.00%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Cabergoline)
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anemia (Hemoglobin decrease)  1  6/20 (30.00%) 
Cardiac disorders   
Sinus Tachycardia  1  2/20 (10.00%) 
Eye disorders   
Dry eye  1  1/20 (5.00%) 
Gastrointestinal disorders   
Constipation  1  1/20 (5.00%) 
Diarrhea  1  1/20 (5.00%) 
Oral Mucositis  1  1/20 (5.00%) 
Nausea  1  6/20 (30.00%) 
Stomach pain  1  1/20 (5.00%) 
Vomiting  1  1/20 (5.00%) 
General disorders   
Edema limbs  1  1/20 (5.00%) 
Fatigue  1  7/20 (35.00%) 
Investigations   
Alanine aminotransferase increased  1  2/20 (10.00%) 
Alkaline phosphatase increased  1  4/20 (20.00%) 
Aspartate aminotransferase increased  1  13/20 (65.00%) 
Blood prolactin abnormal  1  15/20 (75.00%) 
Cardiac troponin 1 increased  1  1/20 (5.00%) 
Creatinine increased  1  2/20 (10.00%) 
INR increased  1  1/20 (5.00%) 
Lymphocyte Count decreased  1  10/20 (50.00%) 
Platelet Count decreased  1  2/20 (10.00%) 
Weight loss  1  1/20 (5.00%) 
White Blood Cell decreased  1  4/20 (20.00%) 
Hyponatremia  1  5/20 (25.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  12/20 (60.00%) 
Hyperkalemia  1  2/20 (10.00%) 
Hypernatremia  1  1/20 (5.00%) 
Hypoalbuminemia  1  9/20 (45.00%) 
Hypocalcemia  1  7/20 (35.00%) 
Hypoglycemia  1  2/20 (10.00%) 
Hypokalemia  1  3/20 (15.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/20 (5.00%) 
Back pain  1  1/20 (5.00%) 
Pain in extremity  1  1/20 (5.00%) 
Nervous system disorders   
Dizziness  1  1/20 (5.00%) 
Headaches  1  1/20 (5.00%) 
Psychiatric disorders   
Insomnia  1  1/20 (5.00%) 
Depression  1  1/20 (5.00%) 
Renal and urinary disorders   
Acute Kidney Injury  1 [1]  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Erythema Multiforme  1  1/20 (5.00%) 
Erythematous papules  1  1/20 (5.00%) 
Vascular disorders   
Hypertension  1  1/20 (5.00%) 
Lymphedema  1  1/20 (5.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Low grade - Not resulting in hospitalization
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Cesar Santa-Maria, MD
Organization: Northwestern University
Phone: 312-695-6180
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01730729     History of Changes
Other Study ID Numbers: NU 12B06
NCI-2012-02039 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STU00071477 ( Other Identifier: Northwestern University IRB# )
First Submitted: November 15, 2012
First Posted: November 21, 2012
Results First Submitted: December 11, 2018
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019