Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
1 other identifier
interventional
141
0 countries
N/A
Brief Summary
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 31, 2007
CompletedOctober 28, 2010
May 1, 2007
May 30, 2007
October 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
one year after last patient in
Secondary Outcomes (3)
Time to progression
one year after last patient in
Overall Survival
one year after last patient in
Toxicity
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic breast cancer
- 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.
You may not qualify if:
- Only bone metastases
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 34037241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Volker Heinemann, PhD, MD
University of Munich - Klinikum Grosshadern
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 30, 2007
First Posted
May 31, 2007
Study Start
October 1, 2002
Last Updated
October 28, 2010
Record last verified: 2007-05