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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Gemcitabine
Herceptin
Capecitabine (Xeloda)
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cancer, Metastatic Breast cancer, Her-2 expression, Gemcitabine, Capecitabine, Herceptin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
  • 401 Military Hospital of Athens
  • Air Forces Military Hospital of Athens
  • State General Hospital of Larissa, Dep of Medical Oncology
  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

GHer

CapHer

Outcomes

Primary Outcome Measures

Time to progression (TTP) between the two treatment arms

Secondary Outcome Measures

Overall survival
Toxicity profile

Full Information

First Posted
February 26, 2007
Last Updated
February 12, 2013
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00440622
Brief Title
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to poor accrual
Study Start Date
April 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cancer, Metastatic Breast cancer, Her-2 expression, Gemcitabine, Capecitabine, Herceptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
GHer
Arm Title
2
Arm Type
Experimental
Arm Description
CapHer
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Herceptin
Intervention Description
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
Intervention Name(s)
Capecitabine (Xeloda)
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
Primary Outcome Measure Information:
Title
Time to progression (TTP) between the two treatment arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Title
Toxicity profile
Time Frame
During the time of chemotherpy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavrudis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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