Phase 2 Completed N=79 Randomized Treatment

Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

Source: ClinicalTrials.gov NCT00405938 ↗

Enrolled (actual)

Serious AEs

27.9%

Results posted

Feb 2013

Primary outcomePrimary: Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease — 21; 9 months

Summary

This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these combinations will keep the cancer from growing and spreading further.

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	21; 9	—
SECONDARY Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	18; 11	—

Eligibility Criteria

Inclusion Criteria

Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis
Female patients 18 years or older
Documentation of ER+ and/or PR+
No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
Measurable or evaluable disease
Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
Must have adequate bone marrow, renal and liver function
Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction

Exclusion Criteria

No metastatic disease to the Central Nervous System
No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months
No symptoms of peripheral vascular disease
No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
No known hypersensitivity to phosphate, trehalose or polysorbate
No serious non-healing wound, ulcer or bone fracture
No uncontrolled high blood pressure or history of hypertensive crisis
No New York Hear Association class II congestive heart failure
No extensive cancer involvement of the liver or lungs
No history of significant psychiatric disorders
No significant vascular disease

There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00405938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.