CompletedPhase 2ACTRN12606000507583

ANZ 0601 / CIRG/TORI 010

A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination with Paclitaxel, or Open-Label Bevacizumab in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Sponsor

Amgen Inc.

Enrollment

273 participants

Start Date

Sep 11, 2007

Study Type

Interventional

Conditions

HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Summary

The purpose of this study is to test a new anticancer drug, AMG 706, which targets the blood vessels of the tumour. Evidence suggests that the formation of new blood vessels within the tumour is critical in the progression of solid tumours, including breast cancer. Of the numerous factors that affect the growth of these blood vessels, vascular endothelial growth factor (VEGF) is likely one of the most, if not the most, important molecules regulating new blood vessel formation and subsequent invasion and metastasis. As a result, agents that inhibit VEGF (such as those drugs being used in this trial) may prevent this tumour vascular invasion and thereby block the growth of the tumour.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: ANZ 0601 / CIRG/TORI 010. It is open to women only, aged 18 and older. To take part, you generally need: measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Eligible patients will be randomised in a 3-arm design to receive one of the following: Arm B : Paclitaxel 90mg/m2 IV over 1 hour every week for 3 weeks (days 1, 8, 15, of each 28 day cycle) and bl

Eligible patients will be randomised in a 3-arm design to receive one of the following: Arm B : Paclitaxel 90mg/m2 IV over 1 hour every week for 3 weeks (days 1, 8, 15, of each 28 day cycle) and blinded AMG 706 125mg orally every day. Arm C : Paclitaxel 90mg/m2 IV over 1 hour every week for 3 weeks (days 1, 8, 15, of each 28 day cycle) and open label bevacizumab 10mg/kg IV following paclitaxel treatment on week 1 and week 3 of each cycle. Treatment will be continued until disease progression, unacceptable toxicity or withdrawal of patient consent.

Locations(1)

Australia

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ACTRN12606000507583