Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
NCT ID: NCT00480597
Last Updated: 2010-10-28
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
141 participants
INTERVENTIONAL
2002-10-31
Brief Summary
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For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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gemcitabine
cisplatin
vinorelbine
capecitabine
Eligibility Criteria
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Inclusion Criteria
* All patients were required to give written informed consent
* Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
* Antracycline-pretreatment during aduvant or palliative first line therapy
* Bidimensionally measurable lesion outside a previous radiation field.
* Age \>= 18 years
* Karnofsky Performance status \>= 70%
* Adequate heamatological, renal, cardiac and hepatic function
* No radiation of the measurable lesion during the study was allowed.
Exclusion Criteria
* Active infection
* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy
* Insufficent renal function (creatinine clearance \< 60ml/min)
* Known DPD deficiency
* clinically unstable brain metastasis
* pregancy or lactation
* other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).
18 Years
70 Years
FEMALE
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Principal Investigators
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Volker Heinemann, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Munich - Klinikum Grosshadern
References
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Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Other Identifiers
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Gemcitabin 02 MC
Identifier Type: -
Identifier Source: org_study_id