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Weekly versus three-weekly docetaxel in women with breast cancer

A randomised controlled study of weekly versus three weekly docetaxel in women with breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN09184069
Enrollment
82
Registered
2010-06-02
Start date
2000-07-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Primary breast cancer Cancer Malignant neoplasm of the breast

Interventions

Arm A: 12 cycles of weekly docetaxel intravenously (IV) 100 mg/m2 for 12 weeks treatment Arm B: 4 cycles of three-weekly docetaxel IV 100 mg/m2 for 4 weeks treatment Follow-up for both arms was 75.5

Sponsors

United Lincolnshire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 18 - 70 years 2. Unilateral/bilateral large (greater than or equal to 3 cm) or locally advanced primary breast cancer (T3, T4, TxN2), no distant metastases 3. World Health Organization (WHO) performance status of less than 2 4. Adequate cardiac, haematological, renal, and hepatic function

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Previous malignancy (except curatively treated carcinoma in situ of the cervix or basal cell carcinoma of skin) 3. Previous cytotoxic, endocrine, or radiotherapy 4. Active infection 5. Contraindications to corticosteroid administration 6. Pre-existing neurotoxicity (greater than grade 2) as defined by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) 7. Significant cognitive impairment or dementia 8. Inability to complete quality of life (QoL) questionnaires or provide informed consent

Design outcomes

Primary

MeasureTime frame
Quality of life 3 weeks after completion of chemotherapy

Secondary

MeasureTime frame
1. Clinical and pathological responses at 12 weeks 2. Disease free survival and overall survival at 5 years

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026