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Sponsored by: |
National Cancer Center, Korea |
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Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00532857 |
To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Paclitaxel, Gemcitabine,Trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2008 |
Primary objectives: To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH) Secondary objectives: To assess breast conserving rate after preoperative chemotherapyTo evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the safety profiles of PGH
Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) in addition to trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will receive 6 cycles of therapy unless there is any evidence of no response suitable for operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT.
However, when patients are still suitable for op even with SD or PD, these patients will undergo op.Such decision will be made at physician's discretion at each institution. Also, even though there is neither clear evidence of disease progression nor severe toxicity, if patient declines the treatment, study treatment can be discontinued. Response will be documented by physical examination, sonography and/or chest CT prior to treatment and every three cycles. Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and tamoxifen or AI for 5 years will be given as indicated. Radiation therapy will be initiated postoperatively in 3-4 weeks according to the standard practice guidelines.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute granulocyte count ³1500/mm3,
Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:
Exclusion Criteria:
Contact: Jungsil Ro, M.D. | 82-31-920-1228 | jungsro@ncc.re.kr |
Contact: Keunseok Lee, M.D |
Korea, Republic of, Gyeonggi-do | |
National Cancer Center | Recruiting |
809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
Contact: Jungsil Ro, MD 82-31-920-1610 jungsro@ncc.re.kr |
Principal Investigator: | Jungsil Ro, MD,PhD | National Cancer Center, Korea |
Study ID Numbers: | NCCCTS-06-235 |
Study First Received: | September 19, 2007 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00532857 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Patients with HER2 + stage II/III breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Antiviral Agents Immunosuppressive Agents |
Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Trastuzumab Gemcitabine Antineoplastic Agents, Phytogenic Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Trastuzumab Gemcitabine Breast Diseases Skin Diseases |
Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic |