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Breast CancerPhase 3NCT00109239

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

A Phase 3 study testing rhuMAb VEGF (Bevacizumab) in people with Breast Cancer, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
rhuMAb VEGF (Bevacizumab)
How many people
Not given
Where
No sites listed yet
Study dates
Nov 2000to Sep 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

About this study

Official title: 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

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
Being tested
rhuMAb VEGF (Bevacizumab)
Keywords
Metastatic Breast Cancer, Metastatic, Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhuMAb VEGF (Bevacizumab)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2005 (estimated)
  2. Study startNov 2000
  3. Study completionSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109239
Sponsor's protocol ID
AVF2119g
Status last verified
Jun 2013
First submitted
26 Apr 2005
Last updated
18 Jun 2014
Results posted
No

Publications

  • 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.

    PubMed 17686822

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhuMAb VEGF (Bevacizumab) in people with Breast Cancer, run by Genentech, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.

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