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

Phase 2

Terminated

• Conditions: Chemotherapy; Breast Cancer, Metastatic
• Interventions: Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)

• Registration Number: NCT01067989
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Study Start: 2010-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)	same treatment for all patients

Primary Outcome Measures

Name	Time	Method
To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Plasma Levels of angiogenic growth factors	At 4 predetermined time points along treatment period.

Trial Locations

Locations (1)

Oncology unit; 🇮🇱 Afula, Israel