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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


Phase 3
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression (TTP) between the two treatment arms

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/03.09

NCT ID:

NCT00440622

Start Date:

April 2003

Completion Date:

November 2008

Related Keywords:

  • Breast Cancer
  • Cancer
  • Metastatic Breast cancer
  • Her-2 expression
  • Gemcitabine
  • Capecitabine
  • Herceptin
  • Breast Neoplasms

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