Cabergoline in Metastatic Breast Cancer

NCT01730729 | Completed Early Phase 1 Results DMC

• 3 other identifiers: NU 12B06NCI-2012-02039STU00071477
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  After 8 weeks (2 cycles) of treament

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  From start of treatment until progression of disease or death

• Treatment Toxicity

  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 at 8 weeks

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

  At baseline and after 4 weeks (1 cycle)

• Correlate Tissue Prolactin Biomarkers With Response to Therapy

  At baseline

Study Arms (1)

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.

Drug: cabergoline

Interventions

cabergoline DRUG

Given orally

Also known as: Dostinex, FCE 21336

Treatment (cabergoline)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Lynn Sage Foundation: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Cesar Santa-Maria, MD
• Organization: Northwestern University

cancertrials@northwestern.edu

312-695-6180

Study Officials

• Virginia Kaklamani

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: February 11, 2013
• Primary Completion: December 15, 2015
• Study Completion: October 27, 2017
• Last Updated: September 17, 2019
• Results First Posted: March 26, 2019

Record last verified: 2019-09

Locations

US (1)