Breast Cancer, Metastatic, Chemotherapy
Conditions
Keywords
metronomic chemotherapy, anti-angiogenic effect, Breast cancer
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.
Interventions
DRUGCyclophosphamide, 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)
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD) | 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Levels of angiogenic growth factors | At 4 predetermined time points along treatment period. |
Countries
Israel
Outcome results
None listed