Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
- 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.
- 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.