Condition category
Cancer
Date applied
24/08/2009
Date assigned
01/09/2009
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Volker Moebus

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes