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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

GHer

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Herceptin

Intervention Type DRUG

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

2

CapHer

Group Type EXPERIMENTAL

Herceptin

Intervention Type DRUG

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

Capecitabine (Xeloda)

Intervention Type DRUG

Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles

Interventions

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Gemcitabine

Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Gemzar Xeloda

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No