A Study of rhuMAb VEGF (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Treated Breast Cancer

NCT00109239 | Completed Phase 3

• 1 other identifier: AVF2119g
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase III, multicenter, randomized, active-controlled, open-label trial is designed to evaluate the efficacy, safety, and pharmacokinetics of rhuMAb VEGF when combined with capecitabine compared with capecitabine alone in subjects with previously treated metastatic breast cancer.

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer; Metastatic; Cancer

Interventions

rhuMAb VEGF (Bevacizumab) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Women \>=18 years of age
• Histologically confirmed carcinoma of the breast with metastatic disease that is currently progressing; in subjects who present with metastatic disease, cytologic confirmation is permissible
• Prior administration of one or two conventional chemotherapy regimens for metastatic disease (Subjects who have had bone marrow or peripheral blood stem cell transplantation in association with chemotherapy are eligible for this study.) -OR-
• No prior chemotherapy for metastatic disease if the subject received a regimen containing both an anthracycline (or anthracenedione) and a taxane as adjuvant therapy and if relapse occurred within 12 months of completing adjuvant chemotherapy
• Prior administration of both an anthracycline (or anthracenedione) and a taxane in either the adjuvant or metastatic setting
• Recovery from reversible toxicities of prior therapy
• Bi-dimensionally measurable disease; at least one target lesion must be bi-dimensionally measurable and at least one target lesion must not have been biopsied recently; all target lesions must be \>=2 cm in longest dimension
• ECOG performance status of 0 or 1
• Use of an effective means of contraception in women of childbearing potential
• Life expectancy of \>=3 months
• Willingness and capability to be accessible for follow-up

You may not qualify if:

• Pleural effusions or bone lesions as the only manifestations of the current metastatic breast cancer
• Known HER2-positive status (either 3+ by immunohistochemistry or positive by FISH), as evaluated at the institution, unless the subject has previously relapsed following Herceptin(R) therapy. Subjects may not continue Herceptin therapy while enrolled in this trial.
• Other primary malignancies (other than basal cell carcinoma of the skin or in situ cervical cancer) within the 5 years preceding Day 0
• Prior radiotherapy to a measurable metastatic lesion(s) if it is to be used as the only lesion to measure response, unless the target lesion within the radiation field is actively progressing and radiotherapy was completed \>=6 months prior to randomization
• Radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for metastatic breast cancer within 21 days prior to Day 0
• Use of bisphosphonates unless initiated at least 21 days before Day 0
• Previous treatment with capecitabine
• Previous treatment with rhuMAb VEGF
• History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke; all subjects must have a baseline CT or MRI of the head.)
• Serious, non-healing wound, ulcer, or bone fracture
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to Day 0
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations other than in the breast within 7 days prior to Day 0; placement of a vascular access device within 7 days prior to Day 0
• Current or recent (within 10 days prior to Day 0) use of full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters; for subjects receiving warfarin, international normalized ratio \[INR\] of \<1.5; appropriate use of heparin should be discussed with the Medical Monitor)
• Chronic, daily treatment with aspirin (\>325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
• Presence of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• Scappaticci FA, Skillings JR, Holden SN, Gerber HP, Miller K, Kabbinavar F, Bergsland E, Ngai J, Holmgren E, Wang J, Hurwitz H. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst. 2007 Aug 15;99(16):1232-9. doi: 10.1093/jnci/djm086. Epub 2007 Aug 8.

  PMID: 17686822 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2005
• First Posted: April 26, 2005
• Study Start: November 1, 2000
• Study Completion: September 1, 2002
• Last Updated: June 18, 2014

Record last verified: 2013-06