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A Multicenter, Open-Label, Phase III, Randomized, Active-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of rhuMAb VEGF (Bevacizumab), in Combination With Capecitabine Chemotherapy, in Subjects With Previously Treated Metastatic Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Phase III, Randomized, Active-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of rhuMAb VEGF (Bevacizumab), in Combination With Capecitabine Chemotherapy, in Subjects With Previously Treated Metastatic Breast Cancer

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

- Active infection requiring parenteral antibiotics on Day 0

- Pregnancy (positive pregnancy test) or lactation

- Proteinuria at baseline or clinically significant impairment of renal function

- Severe renal impairment (creatinine clearance <30 mL/min at baseline using the
Cockcroft-Gault formula)

- Known sensitivity to 5-FU

- Lack of physical integrity of the upper gastrointestinal tract, known malabsorption
or other significant disease of the stomach, small intestine, liver, or kidney that
may adversely affect the pharmacokinetics of capecitabine

- History of allergy to iodine-containing contrast that required treatment and that
would prohibit use of CT scan with contrast

- Screening clinical laboratory values: *ANC of <1500/uL; *Platelet count of
<75,000/uL; *INR of >=1.5; *Total bilirubin of >1.5 times upper limit of normal; *AST
or ALT >2.5 times the upper limit of normal (>5 times the upper limit of normal in
subjects with known metastatic disease in the liver); *Serum creatinine of >2.0
mg/dL; *Hemoglobin of <9 gm/dL (may be transfused to maintain or exceed this level)

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications

- Current or recent (within 28 days prior to Day 0) participation in another
experimental drug study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

November 2000

Completion Date:

September 2002

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic
  • Cancer
  • Breast Neoplasms