Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Gemcitabine (Drug); Herceptin (Drug); Capecitabine (Xeloda) (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Hellenic Oncology Research Group Official(s) and/or principal investigator(s): Dimitris Mavrudis, MD, Principal Investigator, Affiliation: University Hospital of Crete
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to progression (TTP) between the two treatment arms
Secondary outcome: Overall survivalToxicity profile
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
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
Additional Information
Starting date: April 2003
Last updated: February 12, 2013
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