Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Oxaliplatin
Intervention description: Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.; Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.
For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Intervention MeSH terms: Oxaliplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; HER2/neu+

Summary:

      This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second
      line therapy in patients with stage IV, metastatic breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ≥ 18 years of age

          -  Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +)
             and evidence of metastatic disease. Tumor may be of any estrogen and progesterone
             receptor type

          -  Measurable disease by RECIST and an ECOG ≤ 2

          -  Patients with known evidence of brain metastases are eligible if they are asymptomatic
             and have completed all therapy (surgery, radiotherapy, and/or steroids)

          -  Baseline LVEF value within the institutional normal range

          -  Any number of prior hormonal therapy treatments in the adjuvant setting or for
             metastatic disease. A subject must have progressed on hormonal therapy and all
             hormonal therapy (including birth control pills) must be discontinued at study entry.

          -  Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen
             for metastatic disease is allowed.

          -  Patients may have received one prior trastuzumab/chemotherapy containing regimen or
             prior single agent trastuzumab.

          -  Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it
             was not to the only site of evaluable disease.

          -  All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2
             weeks before enrollment.

          -  Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate
             were started within < 2 months prior to enrollment, the bone lesions will not be
             evaluated for response and the patient must have another site of metastatic disease
             that is either measurable or evaluable for response.

          -  Patients must have recovered from toxicities due to prior therapy.

          -  Lab values in accordance with the protocol

          -  Patients must be nonpregnant and nonlactating. Patients of childbearing potential must
             implement an effective method of contraception during the study (birth control pills
             are not allowed).

        Exclusion Criteria:

          -  Bone only disease are ineligible

          -  Patients who received more than 1 prior chemotherapy regimen for metastatic disease
             are ineligible.

          -  Patients with a history of other cancers except curatively-treated carcinoma of the
             cervix in situ or non-melanomatous skin cancer.

          -  Active serious infection or other underlying medical condition that would impair their
             ability to receive protocol treatment.

          -  Uncontrolled nervous system metastases

          -  Dementia or significantly altered mental status that would interfere with proper
             consenting.

          -  Receiving other investigational therapy.