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Breast CancerPhase 2NCT00107393

Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

A Phase 2 study testing trastuzumab and capecitabine in people with Breast Cancer, run by Tohoku University at 10 sites in Japan.

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

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab and capecitabine
How many people
75 participants
Where
10 sitesJapan
Study dates
Jun 2003to Nov 2008
Phase
Phase 2
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 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Metastatic disease
  • Patients with only bone metastases are not eligible
  • Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting
  • Total neoadjuvant or adjuvant taxane dose > 700 mg/m^2 for paclitaxel or > 240 mg/m^2 for docetaxel
  • Total taxane dose > 350 mg/m^2 for paclitaxel or > 120 mg/m^2 for docetaxel in the metastatic setting
  • Total neoadjuvant or adjuvant anthracycline dose > 240 mg/m^2 for doxorubicin or epirubicin
  • Total anthracycline dose > 120 mg/m^2 for doxorubicin or epirubicin in the metastatic setting
  • HER2/neu overexpression
  • 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
  • No symptomatic brain metastases
  • No pleural or pericardial effusion or ascites
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 20 to 75

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (< 3.0 times ULN for patients with liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine ≤ 1.2 mg/dL

Cardiovascular

  • LVEF > 50%

Pulmonary

  • No interstitial pneumonia with pulmonary fibrosis

Other

  • No history of hypersensitivity reactions
  • No serious, uncontrolled infection
  • No other malignancy
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior trastuzumab (Herceptin®) for metastatic disease allowed

Chemotherapy

  • See Disease Characteristics
  • No prior capecitabine
  • At least 2 weeks since prior antimetabolites for metastatic disease
  • At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents

Endocrine therapy

  • At least 4 weeks since prior goserelin or leuprolide for metastatic disease
  • At least 2 weeks since prior oral endocrine agents for metastatic disease
  • No concurrent endocrine therapy

Radiotherapy

  • No prior radiotherapy to target lesions
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy, including radiotherapy for brain metastases

Surgery

  • Not specified

Other

  • Concurrent bisphosphonates for bone metastases allowed

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Japan10 sites

  • Kitakyushu Municipal Medical Center

    Fukuoka, 802-0077

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Saint Marianna University School of Medicine

    Kanagawa, 216-8511

  • National Hospital Organization - Osaka National Hospital

    Osaka, 540-0006

  • Osaka Kosei Nenkin Hospital

    Osaka, 553-0003

  • Osaka University Graduate School of Medicine

    Osaka, 565-0871

  • Tohoku University Graduate School of Medicine

    Sendai, 980-8574

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Sakata Municipal Hospital

    Yamagata, 998-8585

Other trials in Japan

About this study

Official title: Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with capecitabine works in treating women with metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the median survival time and 2-year survival rate in women with taxane- and anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with trastuzumab (Herceptin®) and capecitabine.

Secondary

  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the clinical benefit rate of this regimen in these patients.
  • Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with trastuzumab (Herceptin®) (yes vs no), HER2/neu status (3+ by immunohistochemistry vs positive by fluorescence in situ hybridization), and class of refractory disease (primary vs secondary vs treatment discontinuation due to adverse events).

Patients receive oral capecitabine once daily on days 1-21 and trastuzumab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 3 years.

Conditions
Breast Cancer
Keywords
recurrent breast cancer, stage IV 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.

What is being measured

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

  1. Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment

Secondary outcomes (4)

  1. Progression-free survival

  2. Response rate

  3. Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment

  4. Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment

Timeline

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

  1. First posted6 Apr 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionMay 2008
  4. Study completionNov 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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107393
Sponsor's protocol ID
TUGSM-UHA-BC03-01
Other IDs
CDR0000380787
Status last verified
Oct 2006
First submitted
5 Apr 2005
Last updated
10 Jul 2013
Results posted
No

Publications

  • Ishida T, Kiba T, Takeda M, Matsuyama K, Teramukai S, Ishiwata R, Masuda N, Takatsuka Y, Noguchi S, Ishioka C, Fukushima M, Ohuchi N. Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes. Cancer Chemother Pharmacol. 2009 Jul;64(2):361-9. doi: 10.1007/s00280-008-0882-8. Epub 2008 Dec 12.

    PubMed 19082596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab and capecitabine in people with Breast Cancer, run by Tohoku University at 10 sites in Japan.

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

Who may be eligible to take part?

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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment. 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 NCT00107393, 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 10 Jul 2013.

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