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Breast CancerPhase 4NCT00121836

A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

A Phase 4 study testing Capecitabine and Bevacizumab in people with Breast Cancer, run by Hoffmann-La Roche at 57 sites in United States.

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 single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week… 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?
Capecitabine and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
57 sitesUnited States
Study dates
Jun 2005to Dec 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Women >=18 years of age
  • HER2-negative metastatic breast cancer
  • Previous adjuvant chemotherapy or hormonal treatment
  • >=1 measurable target lesion

Who cannot join

  • Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
  • Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
  • Central nervous system metastases
  • Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
  • Serious concurrent infection

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Study site

    Abingdon, Virginia, 24211

  • Study site

    Atlanta, Georgia, 30341

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Beaufort, South Carolina, 29902

  • Study site

    Birmingham, Alabama, 35022

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35211

  • Study site

    Birmingham, Alabama, 35213

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Bonita Springs, Florida, 34135

  • Study site

    Boynton Beach, Florida, 33435

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Brick, New Jersey, 08724

  • Study site

    Burbank, California, 91505

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cape Coral, Florida, 33990

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Florence, South Carolina, 29506

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Fort Myers, Florida, 33908

  • Study site

    Glendale, California, 91204

  • Study site

    Glendale, California, 91206

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Hilton Head Island, South Carolina, 29926

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46219

  • Study site

    Kansas City, Missouri, 64064

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    Kansas City, Missouri, 64154

  • Study site

    Kansas City, Missouri, 66112

  • Study site

    Kansas City, Missouri, 66210

  • Study site

    Lansing, Michigan, 48909

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Los Angeles, California, 90057

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Naples, Florida, 34102

  • Study site

    Naples, Florida, 34119

  • Study site

    Neptune City, New Jersey, 07754

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    Prince Frederick, Maryland, 20678

  • Study site

    Red Bank, New Jersey, 07701

  • Study site

    Rochester, New York, 14642

  • Study site

    San Diego, California, 92121

  • Study site

    Sarasota, Florida, 34232

  • Study site

    Sarasota, Florida, 34236

  • Study site

    Scarborough, Maine, 04074

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Tucker, Georgia, 30084

  • Study site

    Venice, Florida, 34292

  • Study site

    Waterloo, Iowa, 50702

Other trials in United States

About this study

Official title: An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

    1000 mg/m² PO BID on Days 1-15 of each 3-week cycle

  • BevacizumabDrug

    Also called Avastin

    15 mg IV on Day 1 of each 3-week cycle

Study groups in NCT00121836
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Capecitabine; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death

    Measured: approximately 505 days (Median Time to Death)

Secondary outcomes (3)

  1. Number of Subjects With Adverse Events

    The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

    Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.

    Measured: Throughout study

  2. Premature Withdrawal From Study Due to Adverse Events

    The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.

    Measured: Throughout study

  3. Number of Participants With Marked Laboratory Abnormalities

    The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.

    Measured: until progressive disease or for up to 3 years

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2008
  4. Study completionDec 2008

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121836
Sponsor's protocol ID
ML18527
Status last verified
Apr 2011
First submitted
18 Jul 2005
Last updated
27 Apr 2011

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Capecitabine and Bevacizumab in people with Breast Cancer, run by Hoffmann-La Roche at 57 sites in United States.

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 4 inclusion and 5 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 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Overall Survival (time frame: approximately 505 days (Median Time to Death)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121836.

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 27 Apr 2011; AzTrials last refreshed its copy on 26 Oct 2026.

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