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

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.