Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	18 and over	Other	EORTC-10001 EORTC-16001O, IDBBC-EORTC-10001, NCT00049660

Objectives

Phase II Study:

1. Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine.
2. Compare the duration of response in patients treated with these drugs.

Phase III Study:

1. Compare overall and progression-free survival in patients treated with these drugs.
2. Compare time to treatment failure in patients treated with these drugs.
3. Compare overall safety of these drugs in these patients.
4. Compare quality of life and clinical benefit response in patients treated with these drugs.

Entry Criteria

Disease Characteristics:

• Histologically confirmed breast cancer



• Metastatic disease



• Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting
  • Taxane-resistant disease allowed regardless of duration of prior therapy

     [Note: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane]

  • Taxane-sensitive disease allowed if at least 4 prior courses were received

     [Note: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane]




• Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines



• At least one unidimensionally measurable lesion (phase II study)



• No CNS metastases



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent biologic therapy

Chemotherapy

• See Disease Characteristics
• No more than 2 prior chemotherapy lines for metastatic disease
• No prior capecitabine, vinca alkaloids, or continuous fluorouracil
• No other concurrent chemotherapy

Endocrine therapy

• Prior hormonal therapy allowed
• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study
• No other concurrent investigational treatment
• No concurrent brivudine with capecitabine

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• No symptomatic ventricular arrhythmias
• No clinically significant congestive heart failure
• No clinical or ECG evidence of myocardial infarction within the past 12 months
• No significant coronary artery disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
• No known or prior sensitivity to fluoropyrimidines, including fluorouracil
• No pre-existing grade 2 or greater neurotoxicity
• No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug
• No psychological, familial, sociological, or geographical condition that would preclude study compliance

Expected Enrollment

A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive).

• Phase II: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days.
  
  
  
  • Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days.
  
  
  

  In both arms, treatment continues in the absence of progression or unacceptable toxicity.

  If sufficient response rate is determined in phase II, the phase III study is initiated.




• Phase III: Patients are randomized and receive treatment as in phase II.

Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression.

Clinical benefit response is assessed daily while patient is on study.

Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter.

Pajk B, Cufer T, Canney P, et al.: Anti-tumor activity of capecitabine and vinorelbine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: findings from the EORTC 10001 randomized phase II trial. Breast 17 (2): 180-5, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Martine Piccart-Gebhart, MD, PhD, Study coordinator		Ph: 32-2-541-3206 Email: martine.piccart@bordet.be
Chris Twelves, MD, BMedSci, FRCP, Study coordinator(Contact information may not be current)		Ph: 44-141-211-1712

Registry Information
Official Title		A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
Trial Start Date		2002-09-17
Registered in ClinicalTrials.gov		NCT00049660
Date Submitted to PDQ		2002-09-19
Information Last Verified		2004-12-02

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