Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561119
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : May 1, 2017
Korean Cancer Study Group
Information provided by (Responsible Party):
Young-Hyuck Im, Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: gemcitabine , paclitaxel Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Arm 1
Observation after 6 cycles of gemcitabine plus paclitaxel till progression
Experimental: Arm 2
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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  1. a) overall survival b) quality of life c) toxicity of GP chemotherapy d) duration of response [ Time Frame: approximately 4 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561119

Korea, Republic of
Hanlym University Hospital
Anyang, Kyeongki-Do, Korea, Republic of, 431-070
Bundang Seoul National University Hospital
Bundang, Kyeongki-Do, Korea, Republic of, 463-707
Ajou University University Hospital
Suwon, Kyungki-Do, Korea, Republic of
Yeungnam University Hospital
Kyungsan, Kyungsangbuk-Do, Korea, Republic of
Daegu Patima Hospital
Daegu, Korea, Republic of, 701-600
Inha University School of Medicine
Inchon, Korea, Republic of, 400-711
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei University Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
National Cancer Center
Seoul, Korea, Republic of, 140-320
Kunkuk University Hospital
Seoul, Korea, Republic of, 143-729
Ewha University Hospital
Seoul, Korea, Republic of, 911-1
Asan Medical Center
Seoul, Korea, Republic of
Soonchunhyang University Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Samsung Medical Center
Korean Cancer Study Group
Principal Investigator: Young-Hyuck Im, M.D., Ph.D Samsung Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Young-Hyuck Im, Professor, Samsung Medical Center Identifier: NCT00561119     History of Changes
Other Study ID Numbers: 2007-03-003
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Young-Hyuck Im, Samsung Medical Center:
maintenance chemotherapy
metastatic or recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs