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

Phase 3

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: Herceptin; Drug: Capecitabine (Xeloda)

• Registration Number: NCT00440622
• Lead Sponsor: Hellenic Oncology Research Group

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine	GHer
1	Herceptin	GHer
2	Herceptin	CapHer
2	Capecitabine (Xeloda)	CapHer

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP) between the two treatment arms	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
Toxicity profile	During the time of chemotherpy

Trial Locations

Locations (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa, Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, 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

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece