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 |
| Protocol serial number | RC 40 |
| Sponsor | AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany) |
| Funders | Roche Pharma (Germany), Amgen (Germany) |
- 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
Scientific
Staedtisches Klinikum Frankfurt-Hoechst
Gotenstrasse 6-8
Frankfurt / M
65929
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-arm, interventional phase I/II pilot study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Ethics Committee State of Hessen, Germany approved on the 15th February 2003 (ref: 38/2003) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Capecitabine, vinorelbine, epirubicin, paclitaxel, filgrastim, darbepoetin alfa |
| Primary outcome measure(s) |
Toxicity, assessed during treatment |
| Key secondary outcome measure(s) |
1. Disease free survivial at 3 years |
| Completion date | 15/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2003 |
| Date of final enrolment | 15/07/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Staedtisches Klinikum Frankfurt-Hoechst
Frankfurt / M
65929
Germany
65929
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
