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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00440622
• Other study ID #: CT/03.09
• Status: Terminated
• Phase: Phase 3
• First received: February 26, 2007
• Last updated: February 12, 2013
• Start date: April 2003
• Est. completion date: November 2008

Study information

• Verified date: February 2013
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
• 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
• Capecitabine (Xeloda)
Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles

Locations

Country	Name	City	State
Greece	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

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP) between the two treatment arms		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Toxicity profile		During the time of chemotherpy	Yes