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


Phase 2
18 Years
80 Years
Not Enrolling
Female
Chemotherapy, Breast Cancer, Metastatic

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)

Outcome Time Frame:

6 and 12 months

Safety Issue:

No

Authority:

Israel: Ministry of Health

Study ID:

0078-09-EMC

NCT ID:

NCT01067989

Start Date:

March 2010

Completion Date:

March 2012

Related Keywords:

  • Chemotherapy
  • Breast Cancer, Metastatic
  • metronomic chemotherapy
  • anti-angiogenic effect
  • Breast cancer
  • Breast Neoplasms

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