Weekly versus three-weekly docetaxel in women with breast cancer
| ISRCTN | ISRCTN09184069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09184069 |
| Protocol serial number | Trial 206(n) protocol 1.0 |
| Sponsor | United Lincolnshire Hospitals NHS Trust (UK) |
| Funder | Sanofi-Aventis Pharmaceuticals (UK) |
- Submission date
- 25/02/2010
- Registration date
- 02/06/2010
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Weekly doses of the drug docetaxel have occasionally been used to treat patients with breast cancer. The aim of this study is to compare the effect of weekly versus the standard three-weekly docetaxel treatment on patients’ quality of life.
Who can participate?
Women aged 18 -70 with breast cancer.
What does the study involve?
After 4 cycles of doxorubicin and cyclophosphamide treatment, participants are randomly allocated to receive either 12 cycles of weekly docetaxel or 4 cycles of three-weekly docetaxel.
What are the possible benefits and risks of participating?
Weekly docetaxel may cause fewer side effects and therefore improve patients’ quality of life. The common side effect of chemotherapy is febrile neutropenia (fever).
Where is the study run from?
Lincoln County Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2000 to November 2002
Who is funding the study?
Sanofi Aventis (UK); Royal Thai Army, Bangkok (Thailand); Prince of Songkla University, Songkla (Thailand)
Who is the main contact?
Prof. Oleg Eremin
oleg.eremin@ulh.nhs.uk
Contact information
Scientific
Research & Development
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled study of weekly versus three weekly docetaxel in women with breast cancer |
| Study objectives | The hypothesis was that weekly docetaxel versus three weekly regime resulted in comparable quality of life without compromising treatment efficacy. |
| Ethics approval(s) | Nottinghamshire Research Ethics Committee, 05/04/2000, ref: 206(n) |
| Health condition(s) or problem(s) studied | Primary breast cancer |
| Intervention | 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 months. |
| Intervention type | Drug |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Docetaxel |
| Primary outcome measure(s) |
Quality of life 3 weeks after completion of chemotherapy |
| Key secondary outcome measure(s) |
1. Clinical and pathological responses at 12 weeks |
| Completion date | 01/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target sample size at registration | 82 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2000 |
| Date of final enrolment | 01/11/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
LN2 5QY
United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 18/05/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/01/2016: Plain English summary added.
