Weekly versus three-weekly docetaxel in women with breast cancer

Phase 2

Completed

• Conditions: Primary breast cancer; Cancer; Malignant neoplasm of the breast

• Registration Number: ISRCTN09184069
• Lead Sponsor: nited Lincolnshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-02
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 82

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life 3 weeks after completion of chemotherapy

Secondary Outcome Measures

Name	Time	Method
1. Clinical and pathological responses at 12 weeks<br>2. Disease free survival and overall survival at 5 years