Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line
NCT ID: NCT00191854
Last Updated: 2010-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2005-03-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine + Paclitaxel
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles.
gemcitabine
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
paclitaxel
150 mg/m2, IV, every 14 days x 8 cycles
Gemcitabine + Carboplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles.
gemcitabine
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
carboplatin
Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
Gemcitabine + Cisplatin
gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles
gemcitabine
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
cisplatin
50 mg/m2, IV, every 14 days x 8 cycles
Interventions
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gemcitabine
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
paclitaxel
150 mg/m2, IV, every 14 days x 8 cycles
carboplatin
Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
cisplatin
50 mg/m2, IV, every 14 days x 8 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV disease
* Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
* Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
* Adequate organ function
Exclusion Criteria
* Previous radiation therapy is allowed but must not have included whole pelvis radiation
* Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
* Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9:00 AM to 5:00 PM Est Time (UTC/GMT - 5 hours)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santo André, , Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
São Paulo, , Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, , China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hangzhou, , China
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Nanjing, , China
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Wuhan, , China
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Delhi, , India
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Kolkata, , India
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Ludhiana, , India
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Mumbai, , India
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Pune, , India
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Cuernavaca, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Villahermosa, , Mexico
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Seoul, , South Korea
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Antalya, , Turkey (Türkiye)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gaziantep, , Turkey (Türkiye)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kayseri, , Turkey (Türkiye)
Countries
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Other Identifiers
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B9E-AA-S355
Identifier Type: OTHER
Identifier Source: secondary_id
7451
Identifier Type: -
Identifier Source: org_study_id
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