Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: docetaxel

• Registration Number: NCT00191243
• Lead Sponsor: Eli Lilly and Company

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 and safety in this setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-08
• Study Completion: 2009-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 237

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Gemcitabine	-
A	docetaxel	-
B	Gemcitabine	-
B	docetaxel	-

Primary Outcome Measures

Name	Time	Method
Time to treatment failure (TTTF)	baseline to stopping treatment

Secondary Outcome Measures

Name	Time	Method
Time to progressive disease	baseline to measured progressive disease
Overall survival	baseline to date of death from any cause
Duration of response	time of response to progressive disease
Response rate	baseline to measured progressive disease

Trial Locations

Locations (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.; 🇫🇮 Turku, Finland