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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067989
Recruitment Status : Terminated (No satisfactory acrual)
First Posted : February 12, 2010
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
LOVEN DAVID, HaEmek Medical Center, Israel

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chemotherapy Breast Cancer, Metastatic Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
Study Start Date : March 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: intervention
same treatment for all patients
Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
  1. Cyclophosphamide Tab. 50mg, 1x1/day, continuously.
  2. Capecitabine Tab. 500mg, 1+2/day, continuously.
  3. Methotrexate Tab. 2.5mg, 1x2/day, 2 days every week.
  4. Celecoxib Tab. 200mg, 1x2/day, continuously.
  5. Pamidronate I.V. 90mg, every 4 weeks; or Zoledronate I.V. 4mg, every 4 weeks)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Plasma Levels of angiogenic growth factors [ Time Frame: At 4 predetermined time points along treatment period. ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067989

Oncology unit
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel

Responsible Party: LOVEN DAVID, Oncologist, HaEmek Medical Center, Israel Identifier: NCT01067989     History of Changes
Other Study ID Numbers: 0078-09-EMC
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by LOVEN DAVID, HaEmek Medical Center, Israel:
metronomic chemotherapy
anti-angiogenic effect
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Zoledronic acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors