A multicentre phase II feasibility study of accelerated chemotherapy - sequential epirubicin followed by intravenous cyclophosphamide, methotrexate and fluorouracil - using pegfilgrastim for women with early stage breast cancer
| ISRCTN | ISRCTN07812773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07812773 |
| Protocol serial number | BR2017 |
| Sponsor | University of Birmingham (UK) |
| Funder | Educational grants from Amgen UK and Pfizer UK |
- Submission date
- 07/06/2006
- Registration date
- 11/07/2006
- Last edited
- 03/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Rea
Scientific
Scientific
Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II non-randomised feasibility study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre phase II feasibility study of accelerated chemotherapy - sequential epirubicin followed by intravenous cyclophosphamide, methotrexate and fluorouracil - using pegfilgrastim for women with early stage breast cancer |
| Study acronym | NEAT-A |
| Study objectives | To explore the feasibility and toxicity of accelerated epirubicin, cyclophosphamide, methotrexate and fluorouracil (E-CMF) chemotherapy, using single doses of pegfilgrastim to reduce the interval between chemotherapy cycles, in a cohort of patients who would normally be treated with conventional E-CMF. |
| Ethics approval(s) | Approved by West Hertfordshire Local Research Ethics Committee on 01/11/2004, reference number: 04/Q0203/27 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Patients should be treated according to the following schedule: D1 Epirubicin 100 mg/m^2 intravenous (i.v) administration D2 Pegfilgrastim 6 mg single dose subcutaneous administration (s.c.) Repeated every 14 days for four cycles. Then either: Classical i.v. CMF (option A) D1 Cyclophosphamide 600 mg/m2 i.v. Methotrexate 40 mg/m^2 i.v. 5-Fluorouracil 600 mg/m^2 i.v. D8 Cyclophosphamide 600 mg/m^2 i.v. Methotrexate 40 mg/m^2 i.v. 5-Fluorouracil 600 mg/m^2 i.v. D9 Pegfilgrastim 6 mg single dose s.c. Repeated every 21 days for 4 cycles. Folinic acid (15 mg orally (p.o.) six-hourly times six doses commencing 24 h post methotrexate) should be administered with all cycles of CMF |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Epirubicin, cyclophosphamide, methotrexate, fluorouracil, pegfilgrastim, folinic acid |
| Primary outcome measure(s) |
Delivered dose intensity |
| Key secondary outcome measure(s) |
Toxicity and safety |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 80 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Histological diagnosis of invasive early breast cancer with complete excision following surgery 2. No evidence of metastatic disease 3. Clear indication for adjuvant chemotherapy based on clinical and histopathological features 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Clinically assessed as fit to undergo E-CMF chemotherapy at full dose a. Haematological parameters within normal range for institution b. Liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≤1.5 upper limit of normal (ULN) c. Adequate renal function with creatinine clearance >50 ml/min (calculated according to Cockcroft formula) 6. No previous chemotherapy or radiotherapy 7. Aged 18 years and over 8. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active 9. Written informed consent obtained 10. No concomitant medical or psychiatric problems that might prevent completion of treatment |
| Key exclusion criteria | 1. Significant history of cardiac disease (prior myocardial infarction, angina, uncontrolled hypertension) 2. Any co-morbidity significantly adding to risks associated with cytotoxic chemotherapy for instance: severe chronic obstructive pulmonary disease, poorly controlled diabetes etc 3. Recent exposure to immunosuppressive drugs including oral corticosteroid 4. Inability to comply with protocol requirements |
| Date of first enrolment | 04/03/2005 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cancer Research UK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
B15 2TT
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? |
|---|---|---|---|---|---|
| Abstract results | results | 20/06/2007 | 03/01/2020 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
18/10/2017: No publications found, verifying study status with principal investigator
