A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast cancer

• Conditions: HER2 Negative Locally Recurrent or Metastatic Breast Cancer; MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-000091-32-DE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-18
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 273

Inclusion Criteria

1. Written informed consent must be obtained prior to any study-related procedures.
2. Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
3. Measurable disease per RECIST ( Response Evaluation Criteria in Solid Tumor) guidelines.
4. Complete radiology and tumor measurement within 4 weeks (28 days) prior to registration:
a. Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated.
b. Abdomen: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
c. Pelvis: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
d. Brain: CT scan or MRI
e. Bone: Whole body Bone Scintigraphy.
5. Tumor (primary or metastatic) must be HER2 negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immuno- histochemistry.
6. Female 18 years of age or older at the time the written informed consent is obtained.
7. ECOG Performance Status of 0 or l.
8. Adequate organ and hematological function as evidenced by the following laboratory studies within 2 weeks (14 days) of study registration, unless stated otherwise:
a. Cardiac function
b. Hematological function
c. Renal function
d. Hepatic function
9. Subjects of child- bearing potential and sexually active must provide a negative pregnancy test within 7 days prior to registration and use an accepted and effective non- hormonal method of contraception during study treatment and up to 6 months after last dose of study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 236
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Disease Related
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 registration.
2. Prior chemotherapy for locally recurrent or metastatic breast cancer ( prior endocrine therapy is permitted).
3. Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease unless progression was subsequently documented on at least one of these sites.

Medications
4. Currently or previously treated with bevacizumab or small molecule inhibitors of VEGF including, but not limited to, SU11248 (sunitinib), PTK787 (vatalinib), AZD 2171, AZD 6474, AEE- 788, BAY 43- 9006 (sorafenib) and AMG 706.
5. Treatment with coumadin anticoagulants, (other than low dose prophylaxis for central venous catheters < 1mg/ d) within 7 days prior to study registration.
6. Treatment with rifampin, carbamazepine, rifabutin or phenobarbital within 14 days prior to study registration.

General
7. Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
8. Participation in other investigational device drug trials, or administration of other investigational treatments within 30 days prior to study registration.
9. Pregnant ( i. e., positive beta- human chorionic gonadotropin test) or breast feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified