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Sponsors and Collaborators: |
M.D. Anderson Cancer Center GlaxoSmithKline |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00756470 |
PRIMARY:
The primary objective of the study is to determine the rate of pCR after completion of all protocol specified therapy. This includes the following:
SECONDARY:
Efficacy:
The secondary efficacy objectives of the study are:
This includes the following: Four cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib and FEC75
Safety:
The secondary safety objectives of the study are:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Lapatinib Drug: Paclitaxel Drug: 5-Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu) |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Four cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75.
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Drug: Lapatinib
1500 mg taken by every day by mouth weeks 1-24.
Drug: Paclitaxel
80 mg/m^2 intravenously over 1 hour every three weeks of Weeks 3-12.
Drug: 5-Fluorouracil
500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
Drug: Epirubicin
75 mg/m^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.
Drug: Cyclophosphamide
500 mg/m^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass, involving the majority of the skin of the breast.
Pathologic evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
Willing to under go 1 mandatory core biopsy (2 passes) and 1 mandatory skin biopsy to confirm IBC diagnosis and for biologic expression profiling.Subjects with clinically palpable residual disease may undergo an optional 2nd and 3rd core needle biopsy (1 after initial 2-week Lapatinib therapy and 1 after 6 months of completing all chemotherapy, before surgery) to allow identification of presumed pathways of therapy resistance.
Information may give subject options for other targeted therapies (e.g. trastuzumab) if definitive surgery confirms residual disease.
Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer.
Exclusion Criteria:
Contact: Massimo Cristofanilli, MD | 713-792-2817 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Massimo Cristofanilli, MD |
Principal Investigator: | Massimo Cristofanilli, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Massimo Cristofanilli, MD / Assoc. Professor ) |
Study ID Numbers: | 2007-0818 |
Study First Received: | September 19, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00756470 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Inflammatory Breast Cancer IBC ErbB2 overexpression Lapatinib |
Paclitaxel 5-Fluorouracil Epirubicin Cyclophosphamide Neoadjuvant Chemotherapy |
Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Lapatinib Antimitotic Agents Cyclophosphamide Protein Kinase Inhibitors Epirubicin Immunosuppressive Agents |
Anti-Bacterial Agents Inflammatory Breast Cancer Paclitaxel Fluorouracil Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Protein Kinase Inhibitors Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Skin Diseases Mitosis Modulators |
Breast Neoplasms Enzyme Inhibitors Lapatinib Antimitotic Agents Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |