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Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer
This study is currently recruiting participants.
Verified by Samsung Medical Center, December 2008
Sponsors and Collaborators: Samsung Medical Center
Korean Cancer Study Group
Information provided by: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00561119
  Purpose

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
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • a) overall survival b) quality of life c) toxicity of GP chemotherapy d) duration of response [ Time Frame: approximately 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 326
Study Start Date: May 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: No Intervention
Observation after 6 cycles of gemcitabine plus paclitaxel till progression
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologically Confirmed Metastatic, or Recurrent Breast Cancer
  • Age over 18 Years
  • ECOG Performance Status 0-2
  • Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
  • Life Expectancy ≥ 3 Months
  • Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
  • Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
  • Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
  • Prior Radiation Therapy Allowed as Long as < 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
  • Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  • Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
  • Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
  • No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
  • Written Informed consent.

Exclusion Criteria

  • Serious Uncontrolled Intercurrent Infections
  • Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
  • Pregnancy or Breast Feeding
  • Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
  • Documented Parenchymal or Leptomeningeal Brain Metastasis
  • Peripheral Neuropathy ≥ Grade 2
  • Prior Treatment With Gemcitabine Will Not be Allowed.
  • HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561119

Contacts
Contact: Young-Hyuck Im, M.D., Ph.D 82-2-3410-3445 imyh00@skku.edu
Contact: Jin-Seok Ahn, M.D., Ph.D 82-2-3410-3453 ajis@skku.edu

Locations
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     imyh00@skku.edu    
Contact: Jin-Seok Ahn, M.D., Ph.D     82-2-3410-3453     ajis@skku.edu    
Principal Investigator: Young-Hyuck Im, M.D.            
Sub-Investigator: Jin-Seok Ahn, M.D.            
Sub-Investigator: Yeon-Hee Park, MD, PhD            
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 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 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 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 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.            
Sponsors and Collaborators
Samsung Medical Center
Korean Cancer Study Group
Investigators
Study Chair: Young-Hyuck Im, M.D., Ph.D Samsung Medical Center
  More Information

Responsible Party: Korea Cancer Study Group ( Young-Hyuck Im, Chair of Breast Cancer subcommitte, KCSG )
Study ID Numbers: 2007-03-003
Study First Received: November 18, 2007
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00561119  
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
maintenance chemotherapy
metastatic or recurrent breast cancer
gemcitabine
paclitaxel(GP)

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Breast Neoplasms
Gemcitabine
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009