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

H

HaEmek Medical Center, Israel

Status and phase

Terminated
Phase 2

Conditions

Chemotherapy
Breast Cancer, Metastatic

Treatments

Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)

Study type

Interventional

Funder types

Other

Identifiers

NCT01067989
0078-09-EMC

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

intervention
Experimental group
Description:
same treatment for all patients
Treatment:
Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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