Capecitabine with/without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer

ISRCTN ISRCTN38983527
DOI https://doi.org/10.1186/ISRCTN38983527
Secondary identifying numbers RC 40
Submission date
24/08/2009
Registration date
01/09/2009
Last edited
01/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Volker Moebus
Scientific

Staedtisches Klinikum Frankfurt-Hoechst
Gotenstrasse 6-8
Frankfurt / M
65929
Germany

Study information

Study designSingle-arm, interventional phase I/II pilot study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhase 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
Study objectivesIntegration 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(s)Ethics Committee State of Hessen, Germany approved on the 15th February 2003 (ref: 38/2003)
Health condition(s) or problem(s) studiedBreast cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)Capecitabine, vinorelbine, epirubicin, paclitaxel, filgrastim, darbepoetin alfa
Primary outcome measureToxicity, assessed during treatment
Secondary outcome measures1. Disease free survivial at 3 years
2. Overall survival at 3 years
Overall study start date15/10/2003
Completion date15/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexFemale
Target number of participantsApproximately 50 patients
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/10/2003
Date of final enrolment15/07/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Staedtisches Klinikum Frankfurt-Hoechst
Frankfurt / M
65929
Germany

Sponsor information

AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)
Research organisation

c/o Prof Dr. V. Möbus
Staedtisches Klinikum Frankfurt-Hoechst
Gotenstrasse 6-8
Frankfurt/M
65929
Germany

ROR logo "ROR" https://ror.org/01kjfnp05

Funders

Funder type

Industry

Roche Pharma (Germany)

No information available

Amgen (Germany)
Government organisation / For-profit companies (industry)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan