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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450892 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: lapatinib ditosylate Drug: trastuzumab Procedure: adjuvant therapy Procedure: biopsy Procedure: conventional surgery Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: pharmacological study Procedure: proteomic profiling Procedure: reverse transcriptase-polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase I-II Study of Lapatinib and Docetaxel as Neoadjuvant Treatment for HER-2 Positive Locally Advanced/Inflammatory or Large Operable Breast Cancer |
Estimated Enrollment: | 114 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer meeting one of the following criteria:
Locally advanced or inflammatory disease
No bone, liver, or other extensive metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
No serious cardiac illness or medical condition within the past 6 months including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
United Kingdom, Scotland | |
Edinburgh Cancer Centre at Western General Hospital | Recruiting |
Edinburgh, Scotland, United Kingdom, EH4 2XU | |
Contact: David Cameron, MD 44-131-537-3057 david.cameron@ed.ac.uk |
Study Chair: | David Cameron, MD | Edinburgh Cancer Centre at Western General Hospital |
Study Chair: | Herve Bonnefoi, MD | Hopital Cantonal Universitaire de Geneve |
Study ID Numbers: | CDR0000536482, EORTC-10054, GSK-EORTC-10054, EUDRACT-2006-000864-94 |
Study First Received: | March 20, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00450892 |
Health Authority: | Unspecified |
inflammatory breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Docetaxel Inflammatory breast cancer Skin Diseases Fluorouracil Trastuzumab |
Breast Neoplasms Lapatinib Cyclophosphamide Epirubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Protein Kinase Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |