Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer. PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.

Key facts

Study ID: NCT00232505
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 112
Starts: 2005-11-01
Expected to finish: 2012-08-12
Last updated by the study team: 2017-06-28

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

At least 18 years of age
Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria
No more than three prior chemotherapy regimens either in the adjuvant or metastatic setting.
Histologically documented (either primary or metastatic site) breast cancer that is estrogen receptor- (ER-) negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion. HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory test should be performed when possible, however may participate if fulfill other criteria.
Completion of prior chemotherapy at least 3 weeks prior to study entry.
Patients may have received therapy (ies) in the adjuvant or metastatic setting, however must have discontinued prior to entry. Patients may receive concurrent bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for progression or response.
Radiation therapy must be completed at least 2 weeks prior to study entry, and radiated lesions may not serve as measurable disease.
Patients may have CNS metastases if stable (no evidence of progression) > 3 months after local therapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and life expectancy of at least 6 months.
Adequate organ function defined as:absolute neutrophil count (ANC) > 1500/mm3, plts > 100,000/mm3, creatinine clearance >50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) (or ≤5 x ULN in case of liver metastases); total bilirubin ≤1.5 mg/dL.
Tissue block available for EGFR studies is recommended, although will not exclude patients from participating.
Pregnant or lactating women will be excluded. Women of child bearing potential must have documented negative pregnancy test within two weeks of study entry and agree to acceptable birth control during the duration of the study therapy.
Signed written informed consent.

You may not qualify if…

Lesions identifiable only by PET.
More than three prior chemotherapy regimens (including adjuvant). Sequential regimens such as doxorubicin and cyclophosphamide followed by paclitaxel (AC-paclitaxel) are considered one regimen.
Prior therapy which specifically and directly targets the EGFR pathway with therapeutic intent.
Prior platinum agent for metastatic disease. If platinum agent was used adjuvantly, the patient must have had at least 12 months disease-free interval prior to relapse.
Prior severe infusion reaction to a monoclonal antibody.
Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection).
Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction <45%
Other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study.
Inability to comply with the requirements of the study.

Where it is running

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham — Birmingham, Alabama, United States
UCSF Comprehensive Cancer Center — San Francisco, California, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Washington Cancer Institute at Washington Hospital Center — Washington D.C., District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic Cancer Center — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center — Durham, North Carolina, United States
Rex Cancer Center at Rex Hospital — Raleigh, North Carolina, United States
M. D. Anderson Cancer Center at University of Texas — Houston, Texas, United States
Baylor University Medical Center - Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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