Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107393
First received: April 5, 2005
Last updated: July 9, 2013
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: No ]
  • Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: June 2003
Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107393

Locations
Japan
Kitakyushu Municipal Medical Center
Fukuoka, Japan, 802-0077
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Saint Marianna University School of Medicine
Kanagawa, Japan, 216-8511
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
National Hospital Organization - Osaka National Hospital
Osaka, Japan, 540-0006
Osaka University Graduate School of Medicine
Osaka, Japan, 565-0871
Tohoku University Graduate School of Medicine
Sendai, Japan, 980-8574
St. Luke's International Hospital
Tokyo, Japan, 104-8560
Sakata Municipal Hospital
Yamagata, Japan, 998-8585
Sponsors and Collaborators
Tohoku University
Investigators
Study Chair: Noriaki Ohuchi, MD Tohoku University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00107393     History of Changes
Other Study ID Numbers: TUGSM-UHA-BC03-01, CDR0000380787
Study First Received: April 5, 2005
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014