A randomised phase II study of cytotoxic chemotherapy or cytotoxic chemotherapy combined with celecoxib or trastuzumab as primary chemotherapy for patients with high risk localised breast cancer not amenable to breast conserving therapy
| ISRCTN | ISRCTN10059974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10059974 |
| Protocol serial number | Remagus 0002 |
| Sponsor | Remagus (France) |
| Funders | French government (ref: AOM/2002/02117), Support from Sanofi-Aventis, Roche Pharma and Pfizer |
- Submission date
- 17/11/2006
- Registration date
- 08/02/2007
- Last edited
- 01/02/2019
- 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
Prof Michel Marty
Scientific
Scientific
Centre for Therapeutic Innovations in Oncology and Haematology (CITOH)
Saint Louis University Hospital
1 avenue Claude Vellefaux
Paris
75010
France
| Phone | +33 (0)1 42 49 48 10 |
|---|---|
| m.marty@sls.aphp.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open phase II interventional study |
| Secondary study design | Non randomised study |
| Scientific title | A randomised phase II study of cytotoxic chemotherapy or cytotoxic chemotherapy combined with celecoxib or trastuzumab as primary chemotherapy for patients with high risk localised breast cancer not amenable to breast conserving therapy |
| Study objectives | Addition of celecoxib or trastuzumab to neoadjuvant cytotoxic chemotherapy could increase the pathological response rate. |
| Ethics approval(s) | Approval granted from the local ethics committee (Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Paris Nord) on 14/10/2003. |
| Health condition(s) or problem(s) studied | Localised breast cancer not amenable to breast conserving therapy |
| Intervention | Control arm: Cytotoxic chemotherapy consisting of Epirubicin 75 mg/sqm and cyclophosphamide 750 g/sqm every three weeks for four cycles, followed by docetaxel 100 mg/sqm every three weeks for four cycles, followed by breast surgery. Test arm: Same cytotoxic chemotherapy combined with celecoxib 800 mg/d given during cycles five to eight (Human Epidermal growth factor Receptor (HER2) negative), or trastuzumab 8 mg/kg loading dose then 6 mg/kg every three weeks with docetaxel (cycles five to eight), followed by breast surgery. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Celecoxib, trastuzumab and cytotoxic chemotherapy (epirubicin, cyclophosphamide and docetaxel) |
| Primary outcome measure(s) |
Pathological response rate |
| Key secondary outcome measure(s) |
1. Clinical response rate |
| Completion date | 15/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 340 |
| Key inclusion criteria | 1. Pathologically proven T1c-T4, N0-N1, M0 invasive breast cancer (Tumour, Nodes, Metastasis [TNM] classification) 2. No prior therapy 3. Age 18 to 65 years 4. Available frozen tumour tissue 5. Written informed consent |
| Key exclusion criteria | 1. Male patient 2. Prior therapy for breast cancer 3. Contraindication to study drug(s) 4. Stage IV breast cancer |
| Date of first enrolment | 14/10/2003 |
| Date of final enrolment | 15/09/2007 |
Locations
Countries of recruitment
- France
Study participating centre
Centre for Therapeutic Innovations in Oncology and Haematology (CITOH)
Paris
75010
France
75010
France
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 on pre- and post- therapy detection of circulating tumor cells | 01/04/2010 | Yes | No | |
| Results article | main results | 01/07/2010 | Yes | No | |
| Results article | results | 01/06/2011 | Yes | No | |
| Results article | results | 10/03/2019 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added.
