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Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Hoffmann-La Roche |
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Information provided by: | Spanish Breast Cancer Research Group |
ClinicalTrials.gov Identifier: | NCT00130507 |
Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks. HER2 status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).
Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample size in each arm has been estimated with the Fleming method. Previous data show a clinical benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are needed.
This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36 patients are needed to choose, with a 90% of probability to be right, the best treatment arm, providing it increases benefit rate at least by 15%.
Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment arm.
Patients will be stratified as per investigational site, and presence of visceral metastatic lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive 2 cycles. If no disease progression is detected, treatment must continue until progression or unbearable toxicity.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: trastuzumab Drug: vinorelbine Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Clinical Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line Treatment for HER2 Positive Breast Cancer Patients With Locally Advanced or Metastatic Disease, Progressing to a Previous Therapy Line With Trastuzumab and Taxanes |
Estimated Enrollment: | 82 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematology:
Hepatic function:
Renal function:
Exclusion Criteria:
Spain, Madrid | |
Spanish Breast Cancer Research Group (GEICAM) | |
San Sebastián de los Reyes, Madrid, Spain, 28700 |
Study Chair: | Monserrat Muñoz, MD.,PhD. | Spanish Breast Cancer Research Group |
Study ID Numbers: | GEICAM 2004-06 |
Study First Received: | August 12, 2005 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00130507 |
Health Authority: | Spain: Spanish Agency of Medicines |
HER2 positive breast cancer. Progression to trastuzumab and taxanes. |
Capecitabine Vinorelbine Skin Diseases Trastuzumab Disease Progression |
Neoplasm Metastasis Breast Neoplasms Taxane Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |