Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RC 40
Study information
Scientific title
Phase I/II single-arm interventional pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer
Acronym
Study hypothesis
Integration of the non-cross-resistant chemotherapeutic agents capecitabine and vinorelbine into a intensified dose-dense sequential anthracycline and taxane containing regimen in high-risk early breast cancer (EBC).
Ethics approval
Ethics Committee State of Hessen, Germany approved on the 15th February 2003 (ref: 38/2003)
Study design
Single-arm, interventional phase I/II pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Patients with stage II/IIIA EBC (four or more positive lymph nodes) received post-operative intensified dose-dense sequential epirubicin and paclitaxel with filgrastim and darbepoetin alfa, followed by capecitabine alone (dose levels 1 and 3) or with vinorelbine (dose levels 2 and 4). Capecitabine was given on days 1 to 14 every 21 days at 1,000 or 1,250 mg/m2 twice daily (dose levels 1/2 and 3/4, respectively). Vinorelbine 25 mg/m2 was given on days 1 and 8 of each 21-day course (dose levels 2 and 4). Treatment duration was 24 weeks. Median duration of follow-up is 35.2 months.
Intervention type
Drug
Phase
Phase I/II
Drug names
Capecitabine, vinorelbine, epirubicin, paclitaxel, filgrastim, darbepoetin alfa
Primary outcome measure
Toxicity, assessed during treatment
Secondary outcome measures
1. Disease free survivial at 3 years
2. Overall survival at 3 years
Overall trial start date
15/10/2003
Overall trial end date
15/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years, female
2. Histologically confirmed stage II/IIIA breast cancer with four or more positive axillary lymph nodes
3. Had undergone surgery (complete surgical resection [R0] of breast tumour and axilla) before inclusion in the study
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Left ventricular ejection fraction within the normal institutional range
6. Adequate haematological, renal and hepatic function
7. Provided written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Approximately 50 patients
Participant exclusion criteria
1. Inflammatory breast cancer
2. Received neoadjuvant endocrine therapy, chemotherapy or radiotherapy
3. Known dihydropyrimidine dehydrogenase deficiency
4. Creatinine clearance less than 30 mL/min
5. Impaired organ function
6. Metastatic disease
Recruitment start date
15/10/2003
Recruitment end date
15/07/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Staedtisches Klinikum Frankfurt-Hoechst
Frankfurt / M
65929
Germany
Funders
Funder type
Industry
Funder name
Roche Pharma (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Amgen (Germany)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list