Cetuximab With or Without Carboplatin in Treating Women With Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:November 2005
End Date:December 2016

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Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer

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.

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.

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
We found this trial at
14
sites
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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Durham, NC
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Birmingham, AL
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Boston, MA
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101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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Chapel Hill, NC
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Houston, TX
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One Baylor Plaza
Houston, Texas 77030
(713) 798-4951
Baylor University Medical Center - Houston Baylor University Medical Center in Dallas began in 1903...
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Houston, TX
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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Raleigh, North Carolina 27607
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Raleigh, NC
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San Francisco, California 94115
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San Francisco, CA
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St. Louis, Missouri 63108
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St. Louis, MO
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3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
(202) 687-2110
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
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Washington,
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Washington, District of Columbia 20010
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Washington,
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