Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

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: NCT00440622
Recruitment Status : Terminated (Due to poor accrual)
First Posted : February 27, 2007
Last Update Posted : February 13, 2013
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group

Brief Summary:
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gemcitabine Drug: Herceptin Drug: Capecitabine (Xeloda) Phase 3

Detailed Description:
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer
Study Start Date : April 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Drug: Gemcitabine
Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other Name: Gemzar

Drug: Herceptin
Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV

Experimental: 2
Drug: Herceptin
Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV

Drug: Capecitabine (Xeloda)
Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
Other Name: Xeloda

Primary Outcome Measures :
  1. Time to progression (TTP) between the two treatment arms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
  2. Toxicity profile [ Time Frame: During the time of chemotherpy ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent
  • Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
  • HER-2 overexpression 2+ or 3+ using IHC or FISH +
  • Measurable disease
  • At least one prior chemotherapy regimen
  • Not in a prior irradiation field
  • No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
  • No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
  • Age 18 - 75 year old
  • Performance status (WHO) 0-2
  • Life expectancy more than 12 weeks
  • Absolute neutrophil count > 1500/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  • Adequate liver (bilirubin < 2 mg/dL, SGOT/SGPT < 2 times upper limit of normal, ALP < 3 times upper limit of normal, creatinine < 1.5 upper limit of normal
  • Adequate cardiac function (LVEF > 50%)

Exclusion Criteria:

  • Pregnant or nursing
  • Positive pregnancy test
  • Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
  • Motor or sensory neuropathy > grade 1 according to NCIC toxicity criteria
  • History of allergic reaction attributed to docetaxel
  • Psychiatric illness or social situation that would preclude study compliance
  • Other concurrent uncontrolled illness
  • Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

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): NCT00440622

University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete

Responsible Party: Hellenic Oncology Research Group Identifier: NCT00440622     History of Changes
Other Study ID Numbers: CT/03.09
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Hellenic Oncology Research Group:
Metastatic Breast cancer
Her-2 expression

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