This trial is active, not recruiting.

Condition breast cancer
Treatments cetuximab, carboplatin
Phase phase 2
Target EGFR
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date December 2016
Trial size 112 participants
Trial identifier NCT00232505, CDR0000549855, LCCC 0403, NCT00420329, NCT00492375, P30CA016086


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
Given IV
Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Given IV
Given IV

Primary Outcomes

Overall disease response rate
time frame: every 8 weeks

Secondary Outcomes

Overall survival
time frame: every 4 months
Time to progression
time frame: every 8 weeks

Eligibility Criteria

Female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Metastatic (stage IV) disease - Measurable disease by RECIST criteria - Irradiated lesions are not considered measurable disease - CNS metastases allowed if disease is stable (no evidence of progression) ≥ 3 months after local therapy - No lesions identifiable only by PET scan - HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by FISH - HER2 2+ by IHC allowed - Hormone receptor status: - Estrogen receptor-negative and progesterone receptor-negative tumor PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy ≥ 6 months - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine clearance ≥ 50 mL/min - ALT and AST ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in case of liver metastases) - Bilirubin ≤ 1.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant history of uncontrolled cardiac disease including, but not limited to, any of the following: - Uncontrolled hypertension - Unstable angina - Recent myocardial infarction (within the past 6 months) - Uncontrolled congestive heart failure - Cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction < 45% - No history of severe infusion reaction to monoclonal antibody treatment - No uncontrolled infection - No major medical condition (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction) that may affect study participation - No other significant comorbid condition that may compromise effective and safe participation in the study PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 3 weeks since prior chemotherapy - At least 2 weeks since prior radiation therapy - No more than 3 prior chemotherapy regimens either in the adjuvant or metastatic setting - Sequential regimens (e.g., anthracycline-paclitaxel) are considered 1 regimen - No prior therapy that specifically and directly targets the EGFR pathway with therapeutic intent - No prior platinum agent for metastatic disease - Prior platinum agents in the adjuvant setting allowed provided there was a disease-free interval that lasted for ≥ 12 months prior to relapse - Concurrent bisphosphonates allowed - Bone lesions may not be used to measure progression or response

Additional Information

Official title Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer
Principal investigator Lisa A. Carey, MD
Description OBJECTIVES: Primary - Compare the overall response rate in women with estrogen receptor-negative, progesterone receptor-negative, HER2-nonoverexpressing metastatic breast cancer treated with cetuximab with vs without carboplatin. Secondary - Compare the time to disease progression in patients treated with these regimens. - Correlate downstream effects of EGFR inhibitor on MAPK, AKT, Ki67, and EGFR-dependent signaling, proliferation, and apoptosis with toxicity and response in patients with accessible tumors treated with these regimens. - Determine the changes in biomarkers and gene expression in circulating tumor cells during treatment. - Compare the overall survival rate in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cetuximab IV over 60-120 minutes once a week. - Arm II: Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm II. Blood samples are collected periodically throughout study for correlative biomarker analysis by IHC and gene expression analysis. After completion of study treatment, patients are followed every 4 months.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.