Clinical trial NCT00356681: A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Breast Tumors
Breast Cancer
Locally Recurrent and Metastatic Breast Cancer
Keywords: AMG 706
Paclitaxel
Metastatic Breast Cancer
Antiangiogenic
Bevacizumab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 282
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
* Measurable disease by RECIST guidelines.
* Tumor (primary or metastatic) must be HER2 negative.
* Adequate organ and hematologic function. Exclusion:
* Taxane treatment within 12 months prior to registration.
* Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
* Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
* Current or prior history of central nervous system metastases.
* Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
* History of arterial or venous thrombosis within 1 year prior to registration.
* History of bleeding diathesis or bleeding within 14 days of registration.
* Uncontrolled hypertension (systolic \>145 mmHg; diastolic \>85 mmHg).
* Clinically significant cardiac disease within 12 months of registration.
* Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
* Prior treatment with VEGFr targeted therapies.

Primary outcomes:
measure: Objective response rate, measured radiologically and assessed by an independent review committee.
timeFrame: Last patient enrolled + 16 weeks of treatment
Secondary outcomes:
measure: Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.
timeFrame: >24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21.