Cabergoline in Metastatic Breast Cancer

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01730729
• Collaborator: Lynn Sage Foundation (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 56.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that elevated levels of the hormone prolactin might be associated with an increased risk of breast cancer. Cabergoline has been shown to lower prolactin levels in the blood.

The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Breast Cancer; Stage IV Breast Cancer	Drug: cabergoline	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.

SECONDARY OBJECTIVES:

1. Evaluate the progression-free survival (PFS) and overall survival (OS). II. Evaluate toxicity. III. Correlate serum prolactin levels during therapy with response. IV. Evaluate within-patient changes in computed tomography (CT) and bone scan measurements taken at baseline and after 2 cycles of treatment.

2. Evaluate within-patient changes in prolactin receptor (PRLr) expression from baseline to after 1 cycle of treatment in those patients who consent to optional repeat biopsy.

OUTLINE:

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

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer
• Actual Study Start Date: Feb 11, 2013
• Actual Primary Completion Date: Dec 15, 2015
• Actual Study Completion Date: Oct 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (cabergoline) 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.	Drug: cabergoline; Given orally; Other Names: Dostinex FCE 21336

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate (ORR) at 2 Months [After 8 weeks (2 cycles) of treament]

   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

Secondary Outcome Measures

1. Progression Free Survival (PFS) [From start of treatment until progression of disease or death]

   Progression Free Survival (PFS) will be measured from time of treatment initiation until first documentation of progression of disease or death from any cause.

2. Treatment Toxicity [After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment]

   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.

3. Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles [At baseline and at 8 weeks]

   At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.

4. Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle [At baseline and after 4 weeks (1 cycle)]

   Evaluate prolactin expression in biopsy tissue taken at baseline and after 4 weeks (1 cycle) of treatment.

5. Correlate Tissue Prolactin Biomarkers With Response to Therapy [At baseline]

   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.

6. Overall Survival (OS) [From the start of treatment until death from any cause. Median follow up time of 6.817 months (95%CI 0.22-26.18)]

   Overall Survival (OS) is defined from the first day of treatment until death from any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have histologically confirmed metastatic breast cancer; tissue (a minimum of 3 slides) from the most recent biopsy is required for review and confirmation of eligibility; NOTE: material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available

• Patients must have stage IV breast cancer

• Patients must have tumors (primary or metastatic) that stain positively for the prolactin receptor

• Patients may have measurable or evaluable disease

• Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan

• Evaluable disease is disease that does not meet the criteria for measurable disease; examples would include patients with effusions or bone-only disease

• Women of childbearing potential must commit to the use of effective barrier (non-hormonal) contraception while on study

• Patients must have a life expectancy of greater than 12 weeks

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment

• Leukocytes >= 3,000/uL (microliter)

• Absolute neutrophil count >= 1,500/uL

• Platelets >= 100,000/uL

• Child Pugh score =< 10

• Patients must be able to swallow and retain oral medication

• All patients must have given signed, informed consent prior to registration on study

Exclusion Criteria:

• Women who are pregnant or lactating are not eligible for study treatment

• Patients who are undergoing concomitant radiotherapy are NOT eligible for participation

• Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration

• Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration

• Patients who are receiving concomitant D2-antagonists (such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide) are NOT eligible for participation; patients must be off any such medications by the time of registration

• Patients with known brain metastases are NOT eligible for participation

• Patients with any of the following conditions or complications are NOT eligible for participation:

• Uncontrolled hypertension

• Known hypersensitivity to ergot derivatives

• History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve (to be determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis)

• History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders

• Gastrointestinal (GI) tract disease resulting in an inability to take oral medication

• Malabsorption syndrome

• Require intravenous (IV) alimentation

• History of prior surgical procedures affecting absorption

• Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Lynn Sage Foundation

Investigators

• Principal Investigator: Virginia Kaklamani, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT01730729
• Other Study ID Numbers: NU 12B06; NCI-2012-02039; STU00071477
• First Posted: Nov 21, 2012
• Last Update Posted: Sep 17, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms; Cabergoline

Study Results

Participant Flow

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.

Arm/Group Title	Treatment (Cabergoline)
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
Period Title: Overall Study
STARTED	20
Completed 2 Cycles/Reached 1st Response	18
Treated Cycle 3 and Beyond	6
COMPLETED	6
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Treatment (Cabergoline)
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 Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 60%
>=65 years	8 40%
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5%
Asian	3 15%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5%
White	15 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR) at 2 Months
Description	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

Outcome Measure Data

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)
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
Measure Participants	18
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Progression Free Survival (PFS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	20
Median (95% Confidence Interval) [Months]	1.84

3. Secondary Outcome

Title	Treatment Toxicity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	20
Nausea	6 30%
Fatigue	5 25%
Hyponatremia	3 15%
Alkaline Phosphatase increased	3 15%
Aspartate Aminotansferase increased	2 10%
Hyperglycemia	2 10%
Hypokalemia	2 10%
Vomiting	1 5%
Pain in extremity	1 5%
Acute Kidney Injury	1 5%
Alanine Aminotranserase increased	1 5%
Arthralgia	1 5%
Creatinine increased	1 5%
Diarrhea	1 5%
Dizziness	1 5%
Dry eye	1 5%
Hyperkalemia	1 5%
Hypernatremia	1 5%
Hypocalcemia	1 5%
Hypoglycemia	1 5%
Insomnia	1 5%
Pain	1 5%
White Blood Cell decreased	1 5%

4. Secondary Outcome

Title	Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles
Description	At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.
Time Frame	At baseline and at 8 weeks

Outcome Measure Data

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)
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
Measure Participants	0

5. Secondary Outcome

Title	Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle
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)

Outcome Measure Data

Analysis Population Description

No data collected as no patients completed repeat biopsy after 1 cycle of treatment.

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	0

6. Secondary Outcome

Title	Correlate Tissue Prolactin Biomarkers With Response to Therapy
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

Outcome Measure Data

Analysis Population Description

Only 9 patients had sufficient baseline tissue to be analyzed.

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	9
Stable Disease	170
Progressive Disease	220

7. Secondary Outcome

Title	Overall Survival (OS)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	20
Median (95% Confidence Interval) [Months]	10.41

8. Post-Hoc Outcome

Title	Clinical Benefit Rate (CBR) After 2 Cycles of Treatment
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

Outcome Measure Data

Analysis Population Description

2 patients did not reach the 8 week response assessment time point.

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	18
Count of Participants [Participants]	6 30%

9. Post-Hoc Outcome

Title	Disease Control at 12 Months
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	20
Count of Participants [Participants]	2 10%

10. Post-Hoc Outcome

Title	Best Overall Response
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)

Outcome Measure Data

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)
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
Measure Participants	19
Partial Response	1 5%
Stable Disease	5 25%
Progressive Disease	13 65%

11. Post-Hoc Outcome

Title	Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment
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

Outcome Measure Data

Analysis Population Description

Serum prolactin at baseline and after 2 cycles of treatment were only available for 12 patients.

Arm/Group Title	Treatment (Cabergoline)
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
Measure Participants	12
All	-9.425
Stable Disease	-8.72
Progressive Disease	-9.93

Adverse Events

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.
Arm/Group Title	Treatment (Cabergoline)
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
All Cause Mortality
	Treatment (Cabergoline)
	Affected / at Risk (%)	# Events
Total	13/20 (65%)
Serious Adverse Events
	Treatment (Cabergoline)
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
General disorders
Death NOS	1/20 (5%)	1
Pain	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/20 (10%)	3
Other (Not Including Serious) Adverse Events
	Treatment (Cabergoline)
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Blood and lymphatic system disorders
Anemia (Hemoglobin decrease)	6/20 (30%)
Cardiac disorders
Sinus Tachycardia	2/20 (10%)
Eye disorders
Dry eye	1/20 (5%)
Gastrointestinal disorders
Constipation	1/20 (5%)
Diarrhea	1/20 (5%)
Oral Mucositis	1/20 (5%)
Nausea	6/20 (30%)
Stomach pain	1/20 (5%)
Vomiting	1/20 (5%)
General disorders
Edema limbs	1/20 (5%)
Fatigue	7/20 (35%)
Investigations
Alanine aminotransferase increased	2/20 (10%)
Alkaline phosphatase increased	4/20 (20%)
Aspartate aminotransferase increased	13/20 (65%)
Blood prolactin abnormal	15/20 (75%)
Cardiac troponin 1 increased	1/20 (5%)
Creatinine increased	2/20 (10%)
INR increased	1/20 (5%)
Lymphocyte Count decreased	10/20 (50%)
Platelet Count decreased	2/20 (10%)
Weight loss	1/20 (5%)
White Blood Cell decreased	4/20 (20%)
Hyponatremia	5/20 (25%)
Metabolism and nutrition disorders
Hyperglycemia	12/20 (60%)
Hyperkalemia	2/20 (10%)
Hypernatremia	1/20 (5%)
Hypoalbuminemia	9/20 (45%)
Hypocalcemia	7/20 (35%)
Hypoglycemia	2/20 (10%)
Hypokalemia	3/20 (15%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/20 (5%)
Back pain	1/20 (5%)
Pain in extremity	1/20 (5%)
Nervous system disorders
Dizziness	1/20 (5%)
Headaches	1/20 (5%)
Psychiatric disorders
Insomnia	1/20 (5%)
Depression	1/20 (5%)
Renal and urinary disorders
Acute Kidney Injury	1/20 (5%)
Skin and subcutaneous tissue disorders
Erythema Multiforme	1/20 (5%)
Erythematous papules	1/20 (5%)
Vascular disorders
Hypertension	1/20 (5%)
Lymphedema	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.