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A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer


Inclusion Criteria:



- histologically verified diagnosis of breast carcinoma, at first diagnosis

- restricted previous adjuvant chemotherapy (completed >6 months prior the study)

- measurable and/or non-measurable disease

- previous radiotherapy is allowed if:terminated at least 10 days prior the sudy
therapy, at least one target lesion for evaluation of tumor response has not been
irradiated

- performance status 0-2 (WHO, Zubrod)

- adequate bone marrow reserve defined

- adequate liver / renal functions defined

Exclusion Criteria:

- any prior systematic chemotherapy for metastatic breast cancer

- expected survival time less than 12 weeks

- past or current history of malignant neoplasm other than breast carcinoma

- except for cured non-melanoma skin cancer or curatively treated in situ
carcinoma of the cervix uteri

- known brain metastases/leptomeningeal involvement

- active uncontrolled infection

- symptomatic peripheral neuropathy > grade 2 according to NCI

- patients whose lesions are assessable only by radionuclide scan or patients with
sclerotic bone lesions as the only site of disease

- concomitant illness that is contraindication to the use of corticosteroids

- other concomitant serious illness or medical condition, which may worsen due to the
treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to treatment failure (TTTF)

Outcome Time Frame:

baseline to stopping treatment

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Finland: Finnish Medicines Agency

Study ID:

5758

NCT ID:

NCT00191243

Start Date:

March 2002

Completion Date:

March 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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