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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38983527

Enrollment

Registered

2009-09-01

Start date

2003-10-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of the breast

Interventions

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 b

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Toxicity, assessed during treatment	—

Secondary

Measure	Time frame
1. Disease free survivial at 3 years 2. Overall survival at 3 years	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026