Clinical trial NCT01067989: Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer
Official title: Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chemotherapy
Breast Cancer, Metastatic
Keywords: metronomic chemotherapy
anti-angiogenic effect
Breast cancer
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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:
measure: Plasma Levels of angiogenic growth factors
timeFrame: At 4 predetermined time points along treatment period.
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Oncology unit
Study officials:
References: