Breast Cancer Clinical Trial

Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth.

PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.

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Full Description

PRIMARY OBJECTIVE:

I. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab.

II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer.

III. To assess the association between tumor biomarkers and clinical outcomes (response and survival).

IV. To examine the effect this regimen has on time to progression and survival.

OUTLINE:

Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

View Eligibility Criteria

Eligibility Criteria

Inclusion

Pathologically confirmed invasive breast cancer with ER < 10%, PR < 10%, by IHC, HER2 1+ or 0 or FISH negative
Measurable (>= 1 cm) or assessable disease detectable by imagining or physical exam
Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan
Only one or no prior therapy for metastatic or recurrent breast cancer is allowed
Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should elapse prior to study enrollment
Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior to study enrollment
Prior therapy with bevacizumab is permitted but at least 28 days should elapse from the last bevacizumab treatment prior to study enrollment
ECOG PS or 0-1
Signed protocol specific informed consent prior to registration
Life expectancy greater than 3 months
Please contact study investigator and/or consult the protocol document for specific laboratory criteria
Tissue block available from primary breast cancer
Premenopausal women must have a negative serum or urine pregnancy test prior to starting on study treatment (post-menopausal is defined as > 6 months of amenorrhea prior hysterectomy)

Exclusion

More than or equal to 2 prior regimens for metastatic breast cancer
Leptomeningeal disease
Brain metastasis except for a solitary lesion that was resected or treated with gamma knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI was normal with no residual neurologic deficit
History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
History of irreversible neuropathy
Another malignancy other than carcinoma in situ of the cervix or skin cancer
Active uncontrolled bacterial viral or fungal infection
Active pregnancy or breast feeding
Patients with pre-existing neuropathy >= grade 2
History of myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Patients with previous history of CTCAE grade >= 3 hypersensitivity to paclitaxel or Cremophor EL are not eligible

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

14

Study ID:

NCT01009983

Recruitment Status:

Terminated

Sponsor:

Wake Forest University Health Sciences

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There are 2 Locations for this study

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Ochsner Clinic Foundation
New Orleans Louisiana, 70115, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

14

Study ID:

NCT01009983

Recruitment Status:

Terminated

Sponsor:


Wake Forest University Health Sciences

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