Status:
COMPLETED
Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine. Aim of the study is to assess the optimal dosage ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00191243
Start Date
March 1 2002
End Date
April 1 2009
Last Update
September 12 2019
Active Locations (8)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hämeenlinna, Finland
2
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Helsinki, Finland
3
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jyväskylä, Finland
4
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lappeenranta, Finland