Status:
COMPLETED
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
OBJECTIVES: Primary * Compare the overall response rate in women with estrogen receptor-negative, progesterone receptor-negative, human epidermal growth factor receptor 2 (HER2)-nonoverexpressing me...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic (stage IV) disease
- Measurable disease by RECIST criteria
- Irradiated lesions are not considered measurable disease
- Central nervous system (CNS) metastases allowed if disease is stable (no evidence of progression) ≥ 3 months after local therapy
- No lesions identifiable only by positron emission tomography (PET) scan
- HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by Fluorescence In Situ Hybridization (FISH)
- HER2 2+ by IHC allowed
- Hormone receptor status:
- Estrogen receptor-negative and progesterone receptor-negative tumor
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00232505
Start Date
November 1 2005
End Date
August 12 2012
Last Update
June 28 2017
Active Locations (14)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
3
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
4
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010