Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: panitumumab; paclitaxel; carboplatin; laboratory biomarker analysis; immunohistochemistry staining method
Intervention description: Given IV; Given IV; Given IV; Correlative study; Correlative study
Intervention MeSH terms: Paclitaxel; Carboplatin; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: triple-negative 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.
    

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