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

• Register: ISRCTN
• Last refreshed on: 4 March 2019
• Main ID: ISRCTN10059974
• Date of registration: 08/02/2007
• Prospective Registration: No
• Primary sponsor: Remagus (France)
• Public 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
• 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
• Date of first enrolment: 14/10/2003
• Target sample size: 340
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10059974
• Study type: Interventional
• Study design: Open phase II interventional study (Treatment)
• Phase: Phase II

Countries of recruitment

France

Contacts

• Name: Michel Marty

Key inclusion & exclusion criteria

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

Exclusion criteria:
1. Male patient
2. Prior therapy for breast cancer
3. Contraindication to study drug(s)
4. Stage IV breast cancer


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Localised breast cancer not amenable to breast conserving therapy
Cancer
Breast cancer

Intervention(s)

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.

Primary Outcome(s)

Pathological response rate

Secondary Outcome(s)

1. Clinical response rate
2. Safety

Secondary ID(s)

Remagus 0002

Source(s) of Monetary Support

French government (ref: AOM/2002/02117), Support from Sanofi-Aventis, Roche Pharma and Pfizer

Ethics review

Status:
Approval date:
Contact:

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.

Results

• Results available: Yes
• Date Completed: 15/09/2007