Trastuzumab and Vinorelbine in Advanced Breast Cancer
Condition: Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; vinorelbine
Intervention MeSH terms: Trastuzumab; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The analysis was performed for 2 separate cohorts due to a change in study conduct during the trial (see arm description).
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2 negative; HER2 positive

Summary:

      The purpose of this research study is to see what effects trastuzumab in combination with
      vinorelbine has on breast cancer when the participant has circulating tumor cells that are
      positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2.
      The drug combination of trastuzumab and vinorelbine is an effective treatment for patients
      with breast cancers that are positive for HER2. This trial seeks to determine if the
      combination can also benefit participants whose original breast cancer was HER2 negative but
      whose circulating tumor cells are HER2 positive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic invasive mammary carcinoma. The
             primary cancer must be HER2 negative by fluorescence in situ hybridization and/or
             immunohistochemistry.

          -  Patients must have CTCs with HER2 amplification by FISH.

          -  Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension as 20mm or greater with conventional techniques of as 10mm or
             greater with spiral CT scan.

          -  Study participants must have either archival primary tumor or metastatic tumor tissue
             available to allow analysis to confirm their HER2 status.

          -  Patients must have received at least 1 prior chemotherapy regimen for metastatic
             breast cancer or evidence of disease progression within 6 months of completing
             adjuvant chemotherapy. Patients can receive any number of biological or hormonal
             regimens and remain eligible.

          -  18 years of age or older

          -  Life expectancy of greater than 3 months

          -  ECOG Performance Status of 0, 1 or 2

          -  Normal organ and marrow function as outlined in the protocol

          -  Women of child-bearing potential and men must agree to use adequate contraception
             prior to study entry and for the duration of study participation.

        Exclusion Criteria:

          -  Participants must have recovered from all reversible toxicities related to prior
             therapy before beginning protocol treatment, and may not have any pre-existing
             treatment-related toxicities in excess of grade 2

          -  Participants may not be receiving any other investigational agents while participating
             in this study

          -  Participants may not have received trastuzumab or vinorelbine in the past

          -  Participants receiving any medications or substances that are inhibitors of cytochrome
             P450 isoenzymes in the CYP3A subfamily are ineligible.

          -  EKG abnormalities of known clinical significance, such as prolonged QT.

          -  Left ventricular ejection fraction < 50%

          -  Patients with peripheral neuropathy of any etiology that exceeds grade 1 are
             ineligible

          -  Uncontrolled intercurrent illness

          -  Individuals with symptomatic or progressive brain metastases are ineligible. Subjects
             with treated brain metastases are eligible if they have no radiographic or other signs
             of progression in the brain for 1 month or longer after completion of local therapy.
             Any corticosteroid use for brain metastases must have been discontinued without
             subsequent appearance of symptoms for more than 4 weeks prior to study treatment.

          -  Individuals with active second malignancy are ineligible. Patients that are
             disease-free from a previously treated non-breast malignancy and have a 20% or less
             chance of recurrence are eligible.

          -  Pregnant or breast feeding women

          -  HIV-positive individuals on combination antiretroviral therapy