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

February 26, 2007
February 27, 2007
February 13, 2013
April 2003
November 2008   (Final data collection date for primary outcome measure)
Time to progression (TTP) between the two treatment arms [ Time Frame: 1 year ]
Time to progression (TTP) between the two treatment arms
Complete list of historical versions of study NCT00440622 on Archive Site
  • Overall survival [ Time Frame: 1 year ]
  • Toxicity profile [ Time Frame: During the time of chemotherpy ]
  • Response rate
  • Overall survival
  • Toxicity profile
Not Provided
Not Provided
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
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
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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
  • Experimental: 1
    • Drug: Gemcitabine
    • Drug: Herceptin
  • Experimental: 2
    • Drug: Herceptin
    • Drug: Capecitabine (Xeloda)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
Hellenic Oncology Research Group
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP