Biweekly Docetaxel in Patients With Metastatic Breast Cancer.
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      There is clinical benefit of docetaxel administered to patients who have progressed to 3 or
      more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using
      docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic
      responses are obtained that it never received taxanes.
    

Detailed description: 
      Methodology:

      Prospective non-randomized phase IIa. The selected patients with metastatic breast cancer
      heavily pretreated including those previously treated with taxanes, receive docetaxel
      administered at a dose of 45mg/m2 body surface every 2 weeks to assess the activity of this
      drug.

      Variables:

      Age. Menopausal status. Hormone receptor status. Overexpression of HER2 neu. Location of
      metastatic sites. Performance status (PS) 0-3. comorbidities.

      Case management in the variables (patient subgroups )

      The patients with HER 2 neu overexpression of anti -HER2 therapy will further chemotherapy
      with docetaxel.

      The patients presenting with brain metastases may receive radiation therapy to the brain and
      then at the end of radiotherapy, start docetaxel.

      Patients whose tumors express estrogen receptors and progesterone positive receive treatment
      with docetaxel:

      Where there is visceral crisis and it is shown that they have already progressed to more than
      2 lines of previously administered hormone treatment.

      In no event cytotoxic chemotherapy with concurrent docetaxel was administered to an
      anti-estrogen drug.

      And they can continue only when hormone therapy has achieved complete response measurable
      lesions with docetaxel and opt for a non-cytotoxic anti-estrogen therapy and when it came to
      presenting unacceptable toxicity with docetaxel.

      Evaluations:

      clinical assessment that will include physical examination and review of laboratory studies
      were carried out every 2 weeks before authorizing the housing management of a next cycle.

      The objective assessment of tumor response was carried out by imaging studies (CT) by RECIST
      criteria after administration of the 4 criteria of cycles, a cycle is administered every 2
      weeks with docetaxel at a dose of 45mg/m2.

      Response Criteria

        1. Response tumor shrinkage by royalty over 30%.

        2. Greater than 1 cm in the size of tumor lesions decrease.

        3. Disease-free survival

        4. Progression-free survival.

        5. Stable disease

        6. Improved quality of life that is decreased bone pain, improvement of dyspnea.
    

Intervention name(s): Docetaxel
Intervention type(s): Drug
Intervention description(s): evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy
Other intervention name(s): evaluating the response rate and progression-free interval
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic breast cancer; taxanes; heavily pretreated