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Sponsored by: |
National Cancer Centre, Singapore |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589238 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether combination chemotherapy is more effective with or without carboplatin in treating breast cancer.
PURPOSE: This randomized phase II trial is studying giving paclitaxel together with doxorubicin and cyclophosphamide to see how well it works compared to giving paclitaxel together with doxorubicin, cyclophosphamide, and carboplatin in treating women with locally advanced breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Procedure: biopsy Procedure: conventional surgery Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: protein expression analysis Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Randomised Phase II Trial of Neoadjuvant Weekly Paclitaxel Plus Carboplatin Compared to Weekly Paclitaxel Alone Followed in Both Arms by Doxorubicin and Cyclophosphamide for Operable or Locally Advanced Basal-Like Subtype Breast Cancer Correlating BRCA-1 mRNA and Protein Expression With Carboplatin Response |
Estimated Enrollment: | 72 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to clinical stage (T2-3 vs T4). Patients are randomized to 1 of 2 treatment arms.
All patients will then undergo surgical resection of the tumor.
Patients undergo biopsy for correlative studies. Samples are analyzed for estrogen receptor and progesterone receptor status, and molecular endpoints (CK 5/6, CK14, p53, BRCA, and EGFR) by RT-PCR, immunohistochemistry, protein expression, and gene expression profiling.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive basal-type breast cancer meeting the following criteria:
Clinical T2 (> 2 cm), T3 (> 5 cm), or T4 primary tumors with or without clinical lymph node involvement (N0-3)
T4 tumors are defined by any of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Singapore | |
National Cancer Centre - Singapore | Recruiting |
Singapore, Singapore, 169610 | |
Contact: Wong Nan Soon, MBBS, MRCP, FAMS 65-6-436-8088 |
Principal Investigator: | Wong Nan Soon, MBBS, MRCP, FAMS | National Cancer Centre, Singapore |
Principal Investigator: | Ann Lee Siew Gek | National Cancer Centre, Singapore |
Study ID Numbers: | CDR0000579522, SINGAPORE-NCC-0701 |
Study First Received: | January 3, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00589238 |
Health Authority: | Unspecified |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Skin Diseases Paclitaxel Breast Neoplasms Carboplatin |
Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |