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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00440622

Enrollment

Registered

2007-02-27

Start date

2003-04-30

Completion date

2008-11-30

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cancer, Metastatic Breast cancer, Her-2 expression, Gemcitabine, Capecitabine, Herceptin

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.

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.

Interventions

DRUGGemcitabine

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

DRUGHerceptin

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

DRUGCapecitabine (Xeloda)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to progression (TTP) between the two treatment arms	1 year

Secondary

Measure	Time frame
Overall survival	1 year
Toxicity profile	During the time of chemotherpy

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026