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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HaEmek Medical Center, Israel
• Treatments: Capecitabine; Celecoxib; Cyclophosphamide; Methotrexate; Pamidronate; Zoledronic Acid

Criteria

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.