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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00440622
• Date of registration: 26/02/2007
• Prospective Registration: No
• Primary sponsor: Hellenic Oncology Research Group
• Public title: Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
• Scientific 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
• Date of first enrolment: April 2003
• Target sample size: 90
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00440622
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Greece

Contacts

• Name: Dimitris Mavrudis, MD
• Affiliation: University Hospital of Crete

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Gemcitabine

Drug: Herceptin

Drug: Capecitabine (Xeloda)

Primary Outcome(s)

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

Secondary Outcome(s)

Overall survival [Time Frame: 1 year]

Toxicity profile [Time Frame: During the time of chemotherpy]

Secondary ID(s)

CT/03.09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of Crete