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Sponsors and Collaborators: |
Samsung Medical Center Korean Cancer Study Group |
Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00561119 |
The primary goal of therapy in patients with metastatic breast cancer is palliation and prolongation of life with quality. Although there are no randomized trials comparing chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier phases of metastatic disease and more effective therapies, the median survival of patients treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The duration of chemotherapy in patients responding or stable disease remains controversial, since quality of life is not usually adversely affected and may even be improved in many patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several studies investigated the role of maintenance chemotherapy suggest that maintenance chemotherapy is associated with superior time to progression but no survival gain. However, these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of 1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in metastatic breast cancer patients demonstrated a survival advantage to combination chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several randomized trials showing negative results for survival gain in patients who received maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial demonstrated no difference in PFS or survival between the two arms, their metaanalysis advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP) combination chemotherapy is one of the two regimens which showed definite survival gain with favorable toxicity from a randomized trial, we plan to randomize patients who responded to six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy until disease progression versus observation. We hypothesize that patients who receive maintenance GP chemotherapy will do better in terms of progression free survival.
Condition | Intervention | Phase |
Advanced Breast Cancer |
Drug: gemcitabine , paclitaxel |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III, Multicenter, Randomized Trial of Maintenance Versus Observation After Achieving Clinical Response in Pts With Metastatic or Recurrent Breast Cancer Who Received 6 Cycles of Gemcitabine Plus Paclitaxel(GP) as 1st-Line Chemotherapy |
Estimated Enrollment: | 326 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2011 |
Arms | Assigned Interventions |
Arm 1: No Intervention
Observation after 6 cycles of gemcitabine plus paclitaxel till progression
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Drug: gemcitabine , paclitaxel
Gemcitabine 1250 mg/m2 i.v. Day 1 & 8 Paclitaxel 175 mg/m2 i.v. day 1 repeat every 3 weeks |
Arm 2: Experimental
Maintenance chemotherapy with gemcitabine plus paclitaxel after 6 cycles of gemcitabine plus paclitaxel till progression
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Drug: gemcitabine , paclitaxel
Gemcitabine 1250 mg/m2 i.v. Day 1 & 8 Paclitaxel 175 mg/m2 i.v. day 1 repeat every 3 weeks |
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Young-Hyuck Im, M.D., Ph.D | 82-2-3410-3445 | imyh@smc.samsung.co.kr |
Contact: Jin-Seok Ahn, M.D., Ph.D | 82-2-3410-3453 | ajis@smc.samsung.co.kr |
Korea, Republic of | |||||
Samsung Medical Center | Recruiting | ||||
Seoul, Korea, Republic of, 135-710 | |||||
Contact: Young-Hyuck Im, M.D., Ph.D 82-2-3410-3445 imyh@smc.samsung.co.kr | |||||
Contact: Jin-Seok Ahn, M.D., Ph.D 82-2-3410-3453 ajis@smc.samsung.co.kr | |||||
Principal Investigator: Young-Hyuck Im, M.D. | |||||
Sub-Investigator: Jin-Seok Ahn, M.D. | |||||
Asan Medical Center | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Sung-Bae Kim, MD, PhD | |||||
Contact: Jin-Hee Ahn, MD, PhD | |||||
Principal Investigator: Sung-Bae Kim, M.D. | |||||
Sub-Investigator: Jin-Hee Ahn, M.D. | |||||
Seoul National University Hospital | Recruiting | ||||
Seoul, Korea, Republic of, 110-744 | |||||
Contact: Seock-Ah Im, M. D. 82-2-2072-0850 moisa@snu.ac.kr | |||||
Principal Investigator: Seock-Ah Im, M.D. | |||||
Soonchunhyang University Hospital | Not yet recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Hee-Sook Park 82-2-709-9185 parkhs@hosp.sch.ac.kr | |||||
Principal Investigator: Hee-Sook Park, M.D. | |||||
Sub-Investigator: Nam-Soo Lee, M.D. | |||||
Yonsei University Hospital | Recruiting | ||||
Seoul, Korea, Republic of, 120-752 | |||||
Contact: Hyun-Chul Chung unchung8@yumc.yonsei.ac.kr | |||||
Contact: Joo-Hyuk Sohn 82-2-2228-8135 oncosohn@yumc.yonsei.ac.kr | |||||
Principal Investigator: Hyun-Chul Chung, M.D. | |||||
Sub-Investigator: Joo-Hyuk Sohn, M.D. | |||||
Kunkuk University Hospital | Not yet recruiting | ||||
Seoul, Korea, Republic of, 143-729 | |||||
Contact: So-Young Yoon, M.D. 82-2-2030-7537 greenteamd@gmail.com | |||||
Principal Investigator: So-Young Yoon, M.D. | |||||
National Cancer Center | Recruiting | ||||
Seoul, Korea, Republic of, 140-320 | |||||
Contact: Jungsil Ro, MD, PhD 82-31-920-1610 jungsro@ncc.re.kr | |||||
Contact: Keunsuk Lee, MD, PhD | |||||
Principal Investigator: Jungsil Ro, M.D. | |||||
Sub-Investigator: KeunSuk Lee, M.D. | |||||
Ulsan University Hospital | Not yet recruiting | ||||
Ulsan, Korea, Republic of, 682-714 | |||||
Contact: JaeHoo Park, M.D. 82-52-250-7029 jaehpark@uuh.ulsan.kr | |||||
Contact: Su-JIn Shin 82-52-250-7029 ssj-1020@hanmail.net | |||||
Principal Investigator: Jae-Hoo Park, M.D. | |||||
Sub-Investigator: Su-Jin Shin, M.D. | |||||
Ewha University Hospital | Not yet recruiting | ||||
Seoul, Korea, Republic of, 911-1 | |||||
Contact: Kyoung-Eun Lee, M.D. 82-2-2650-5030 oncolee@ewha.ac.kr | |||||
Principal Investigator: Kyung-Eun Lee, M.D. | |||||
Inha University School of Medicine | Recruiting | ||||
Inchon, Korea, Republic of, 400-711 | |||||
Contact: Moon-Hee Lee 82-32-890-2580 moonhlmd@inha.ac.kr | |||||
Principal Investigator: Moon-Hee Lee, M.D. | |||||
Daegu Patima Hospital | Not yet recruiting | ||||
Daegu, Korea, Republic of, 701-600 | |||||
Contact: Jung-Lim Lee, M.D. 82-11-9590-4096 Jllee@kornet.net | |||||
Principal Investigator: Jung-Lim Lee, M.D. | |||||
Korea, Republic of, Kyeongki-Do | |||||
Bundang Seoul National University Hospital | Not yet recruiting | ||||
Bundang, Kyeongki-Do, Korea, Republic of, 463-707 | |||||
Contact: Jee-Hyun Kim, M.D. 82-31-787-7022 jhkimmd@snu.ac.kr | |||||
Principal Investigator: Jee-Hyun Kim, M.D. | |||||
Hanlym University Hospital | Not yet recruiting | ||||
Anyang, Kyeongki-Do, Korea, Republic of, 431-070 | |||||
Contact: Hyo-Jung Kim, M.D. 82-31-380-3704 hemonc@hallym.or.kr | |||||
Principal Investigator: Hyo-Jung Kim, M.D. | |||||
Korea, Republic of, Kyungki-Do | |||||
Ajou University University Hospital | Not yet recruiting | ||||
Suwon, Kyungki-Do, Korea, Republic of | |||||
Contact: Seok-Yun Kang, M.D. 82-31-219-5989 kngsy01@ajou.ac.kr | |||||
Principal Investigator: Seok-Yun Kang, M.D. | |||||
Korea, Republic of, Kyungsangbuk-Do | |||||
Yeungnam University Hospital | Not yet recruiting | ||||
Kyungsan, Kyungsangbuk-Do, Korea, Republic of | |||||
Contact: Kyeong-Hee Lee Ikhee@medical.yeungnam.ac.kr | |||||
Principal Investigator: Kyeong-Hee Lee, M.D. |
Samsung Medical Center |
Korean Cancer Study Group |
Study Chair: | Young-Hyuck Im, M.D., Ph.D | Samsung Medical Center |
Study ID Numbers: | 2007-03-003 |
First Received: | November 18, 2007 |
Last Updated: | November 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00561119 |
Health Authority: | South Korea: Institutional Review Board |
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