Recurrent Breast CancerEarly Phase 1NCT01730729
Cabergoline in Metastatic Breast Cancer
A Early Phase 1 study testing cabergoline in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2013to 27 Oct 2017
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Being tested
- cabergoline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergolineDrug
Also called Dostinex, FCE 21336
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cabergoline) | Experimental | 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. Receives: Drug: cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) at 2 Months
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
Measured: After 8 weeks (2 cycles) of treament
Secondary outcomes (6)
Progression Free Survival (PFS)
Progression Free Survival (PFS) will be measured from time of treatment initiation until first documentation of progression of disease or death from any cause.
Measured: From start of treatment until progression of disease or death
Treatment Toxicity
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.
Measured: After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment
Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles
At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.
Measured: At baseline and at 8 weeks
Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle
Evaluate prolactin expression in biopsy tissue taken at baseline and after 4 weeks (1 cycle) of treatment.
Measured: At baseline and after 4 weeks (1 cycle)
Correlate Tissue Prolactin Biomarkers With Response to Therapy
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.
Measured: At baseline
Overall Survival (OS)
Overall Survival (OS) is defined from the first day of treatment until death from any cause.
Measured: From the start of treatment until death from any cause. Median follow up time of 6.817 months (95%CI 0.22-26.18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start11 Feb 2013
- Primary completion15 Dec 2015
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Lynn Sage Foundation
- Responsible party
- Sponsor
- Investigators
- Virginia Kaklamani, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730729
- Sponsor's protocol ID
- NU 12B06
- Other IDs
- NCI-2012-02039, STU00071477
- Status last verified
- Sep 2019
- First submitted
- 15 Nov 2012
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01730729
- Acronym / sponsor ID
- NU 12B06
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Lynn Sage Foundation
- Study start
- 11 Feb 2013 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate overall response rate (ORR) of cabergoline in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cabergoline) | Experimental | Drug: cabergolinePatients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- Women of childbearing potential must commit to the use of effective barrier (non-hormonal) contraception while on study
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabergolineAlso: Dostinex, FCE 21336Given orally | Drug | Treatment (cabergoline) |
Primary outcome
Overall Response Rate (ORR) at 2 Months
Time frame: 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
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: From start of treatment until progression of disease or death
Treatment Toxicity
Time frame: After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment
Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles
Time frame: At baseline and at 8 weeks
Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle
Time frame: At baseline and after 4 weeks (1 cycle)
Correlate Tissue Prolactin Biomarkers With Response to Therapy
Time frame: At baseline
Overall Survival (OS)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Kaklamani principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cabergoline in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at 2 Months (time frame: After 8 weeks (2 cycles) of treament). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.