ANZ 0601 / CIRG/TORI 010

Phase 2

Completed

• Conditions: HER2 Negative Locally Recurrent or Metastatic Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000507583
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 273

Inclusion Criteria

Confirmed HER2 negative locally recurrent or metastatic breast cancer (locally recurrent disease must not be amenable to resection with curative intent); measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines; complete radiology and tumor measurement within 4 weeks (28 days) prior to randomization; ECOG Performance Status of 0 or 1; adequate organ and hematological function; negative pregnancy test within 7 days prior registration for patients of child-bearing potential and sexually active; written informed consent signed prior to any study-related procedures.

Exclusion Criteria

1. Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 3 weeks (21 days) prior to study randomisation.2. Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapyis permitted).3. Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepaticchemoembolization on all sites of measurable disease unless disease progression was subsequently documented on at least one of these sites.4. Current or prior history of central nervous system metastasis.5. Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 peripheral neuropathy > grade 2 at registration.6. Average systolic blood pressure > 145 mm Hg or average diastolic blood pressure > 85 mm Hg (average blood pressure of the 3 separate blood pressure values measured according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure).7. History of arterial or venous thrombosis within 1 year prior to randomisation.8. History of bleeding diathesis or bleeding within 14 days of randomisation.9. Major surgical procedure within 4 weeks (28 days) prior to randomisation.10. Minor surgical procedure, placement of access device, or fine needle aspiration within 7 days of randomisation.11. Known positive test for human immunodeficiency virus (HIV), hepatitis C, or malignancy (other than in situ cervical cancer, or basal cell cancer of the skin), unless treated with curative intent and without evidence of disease for = 3 years before study randomisation.12. Clinically significant cardiac disease within 12 months of study randomisation, including myocardial infarction, unstable angina, grade II or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.13. Non-healing wound, ulcer or fracture.14. Ongoing or active infection.15. Positive hepatitis B surface antigen.16. Known chronic hepatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if treatment with paclitaxel and AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer, based on objective response rates. Objective response rate is the percentage of patients assigned to a treatment arm with a confirmed best response of complete response or partial response as determined by an independent review committee. [The primary analysis for the objective response rate will be performed when all patients who are receiving protocol therapy have at least their second radiological image. An updated analysis will be performed when every patient on the study receiving protocol specified therapy have at least 10 months after first dose of study treatment.]