Condition category
Cancer
Date applied
17/11/2006
Date assigned
08/02/2007
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michel Marty

ORCID ID

Contact details

Centre for Therapeutic Innovations in Oncology and Haematology (CITOH)
Saint Louis University Hospital
1 avenue Claude Vellefaux
Paris
75010
France
+33 (0)1 42 49 48 10
m.marty@sls.aphp.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Remagus 0002

Study information

Scientific title

Acronym

Study hypothesis

Addition of celecoxib or trastuzumab to neoadjuvant cytotoxic chemotherapy could increase the pathological response rate.

Ethics approval

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.

Study design

Open phase II interventional study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Celecoxib, trastuzumab and cytotoxic chemotherapy (epirubicin, cyclophosphamide and docetaxel)

Primary outcome measures

Pathological response rate

Secondary outcome measures

1. Clinical response rate
2. Safety

Overall trial start date

14/10/2003

Overall trial end date

15/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

340

Participant exclusion criteria

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

Recruitment start date

14/10/2003

Recruitment end date

15/09/2007

Locations

Countries of recruitment

France

Trial participating centre

Centre for Therapeutic Innovations in Oncology and Haematology (CITOH)
Paris
75010
France

Sponsor information

Organisation

Remagus (France)

Sponsor details

Institut Curie
26 rue d'Ulm
Paris
75005
France
+33 (0)1 43 29 12 42
gerard.pinson@curie.net

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

French government (ref: AOM/2002/02117)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Support from Sanofi-Aventis, Roche Pharma and Pfizer

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results on pre- and post- therapy detection of circulating tumor cells in http://www.ncbi.nlm.nih.gov/pubmed/19850639
2. 2010 main results in http://www.ncbi.nlm.nih.gov/pubmed/20480225
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21525400

Publication citations

  1. Main results

    Pierga JY, Delaloge S, Espié M, Brain E, Sigal-Zafrani B, Mathieu MC, Bertheau P, Guinebretière JM, Spielmann M, Savignoni A, Marty M, A multicenter randomized phase II study of sequential epirubicin/cyclophosphamide followed by docetaxel with or without celecoxib or trastuzumab according to HER2 status, as primary chemotherapy for localized invasive breast cancer patients., Breast Cancer Res. Treat., 2010, 122, 2, 429-437, doi: 10.1007/s10549-010-0939-3.

  2. Results

    Reyal F, Valet F, de Cremoux P, Mathiot C, Decraene C, Asselain B, Brain E, Delaloge S, Giacchetti S, Marty M, Pierga JY, Bidard FC, Circulating tumor cell detection and transcriptomic profiles in early breast cancer patients., Ann. Oncol., 2011, 22, 6, 1458-1459, doi: 10.1093/annonc/mdr144.

  3. Bidard FC, Mathiot C, Delaloge S, Brain E, Giachetti S, de Cremoux P, Marty M, Pierga JY, Single circulating tumor cell detection and overall survival in nonmetastatic breast cancer., Ann. Oncol., 2010, 21, 4, 729-733, doi: 10.1093/annonc/mdp391.

Additional files

Editorial Notes