Clinical trial · Interventional
Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer
Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No satisfactory acrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Metastatic | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intervention
- description
- same treatment for all patients
- interventionNames
- Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
Primary outcomes (1)
- measure
- To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
- timeFrame
- 6 and 12 months
Secondary outcomes (1)
- measure
- Plasma Levels of angiogenic growth factors
- timeFrame
- At 4 predetermined time points along treatment period.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available