Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer

Overview

Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates have shown anti-angiogenic properties on tumor vasculature. This study is meant to test the therapeutic potential of an anti-angiogenic treatment strategy by combining all these agents for metastatic breast cancer patients.

Full Title of Study: “Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
    • Cyclophosphamide Tab. 50mg, 1×1/day, continuously. Capecitabine Tab. 500mg, 1+2/day, continuously. Methotrexate Tab. 2.5mg, 1×2/day, 2 days every week. Celecoxib Tab. 200mg, 1×2/day, continuously. Pamidronate I.V. 90mg, every 4 weeks; or Zoledronate I.V. 4mg, every 4 weeks)

Arms, Groups and Cohorts

  • Experimental: intervention
    • same treatment for all patients

Clinical Trial Outcome Measures

Primary Measures

  • To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
    • Time Frame: 6 and 12 months

Secondary Measures

  • Plasma Levels of angiogenic growth factors
    • Time Frame: At 4 predetermined time points along treatment period.

Participating in This Clinical Trial

Inclusion Criteria

  • Histologic proof of infiltrating duct carcinoma of breast. – Her-2 negative tumors. – ECOG performance status: 0-1. – Presence of measurable disease: primary and/or metastatic. – CBC showing normal values or any toxicity limited to grade I. – SMA showing liver and renal functions < 1.5 normal values – previous treatment with an anthracycline and with a taxane is mandatory either as neoadjuvant/adjuvant treatment or for metastatic disease. – previous treatment by chemotherapy for metastatic disease is allowed (up to three lines, allowing for MTD Capecitabine to be one of them). – previous treatment by a bisphosphonate is allowed. However,those patients who up to the study had not received any bisphosphonate and those who had received Clodronate- will receive Pamidronate; those who had been under Pamidronate- will receive Zoledronate; those who had been under Zoledronate- will continue with it." – The patient's signature on the informed consent. Exclusion Criteria:

  • Her-2 neu positive tumor – Inability to visit the clinic for outpatient treatment and evaluation – Active/symptomatic brain metastases. – ECOG performance status: 2-4. – Presence of Hand -Foot syndrome, at grade > 2. – CBC with any grade >2 toxicity – SMA showing liver functions > 1.5 normal values – SMA showing renal functions > normal values -Current continuous treatment by steroids or by NSAIDs, or by anti- coagulants for "non protocol" reasons. – presence of exclusively non-measurable disease (I/E: exclusive bone disease with non-representative tumor markers). – previous radiotherapy to the "only measurable disease". – pleural or peritoneal effusion that may represent a "third space". – history of active peptic ulcer. – symptomatic coronary heart disease.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Principal Investigator: LOVEN DAVID, Oncologist – HaEmek Medical Center, Israel

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