Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
237 participants
INTERVENTIONAL
2002-03-31
2009-04-30
Brief Summary
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Aim of the study is to assess the optimal dosage and safety in this setting.
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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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A
Gemcitabine
A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure
docetaxel
A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
B: 80 mg/m2, IV, q 21 days until treatment failure
B
Gemcitabine
A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure
docetaxel
A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
B: 80 mg/m2, IV, q 21 days until treatment failure
Interventions
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Gemcitabine
A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression
B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure
docetaxel
A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine
B: 80 mg/m2, IV, q 21 days until treatment failure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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
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
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.
Oulu, , Finland
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.
Pikonlinna, , Finland
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.
Pori, , Finland
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
Countries
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References
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Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhonen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol. 2010 May;21(5):968-73. doi: 10.1093/annonc/mdp397. Epub 2009 Oct 9.
Other Identifiers
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B9E-MC-S241
Identifier Type: OTHER
Identifier Source: secondary_id
5758
Identifier Type: -
Identifier Source: org_study_id
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