Author Contributions: Dr Brain, as principal
investigator, had full access to all of the data in the study and takes responsibility
for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Brain, Extra, Combe,
Acquisition of data: Brain, Bachelot, Serin,
Kirscher, Graic, Eymard, Rouëssé.
Analysis and interpretation of data: Brain,
Bachelot, Eymard, Extra, Combe, Noguès, Rouëssé, Fourme.
Drafting of the manuscript: Brain, Serin, Graic,
Extra, Combe, Rouëssé.
Critical revision of the manuscript for important
intellectual content: Brain, Bachelot, Serin, Kirscher, Eymard, Extra,
Combe, Noguès, Rouëssé, Fourme.
Statistical analysis: Brain, Extra, Combe,
Noguès, Rouëssé, Fourme.
Obtained funding: Brain, Combe, Rouëssé.
Administrative, technical, or material support:
Study supervision: Brain, Serin, Extra, Combe,
Financial Disclosures: None reported.
Funding/Support: René Huguenin Cancer
Centre was the sponsor of the RAPP-01 trial. This work was also supported
in part by Aventis–Oncology France and the Ligue Régionale Contre
le Cancer du Département des Yvelines (78). Aventis–Oncology
France supplied the docetaxel.
Role of the Sponsor: Staff in the departments
of medical oncology, radiotherapy biology, pathology, and biostatistics of
the René Huguenin Cancer Centre designed and conducted the study, including
collection and analysis of the data, interpretation of the results, and preparation
of the manuscript. Aventis–Oncology France had no role in the preparation
of the manuscript.
Previous Presentation: Presented as a poster
at the 40th annual meeting of the American Society of Clinical Oncology; June
5-8, 2004; New Orleans, La.
Acknowledgment: We thank the investigators
of the RAPP-01 Trial (institutions: René Huguenin Cancer Centre [Saint-Cloud],
Henri Becquerel Cancer Centre [Rouen], Léon Bérard Cancer Centre
[Lyon], Jean Godinot Cancer Centre [Reims], Institut Curie [Paris], Sainte
Catherine Institute Breast Clinic [Avignon], Centre Hospitalier du Mans [Le
Mans], Paul Papin Cancer Centre [Angers], Claude Bernard Clinic [Metz], Edouard
Herriot University Hospital [Lyon], Civil and University Hospitals of Strasbourg
[Strasbourg]) and the members of the independent data monitoring committee
who helped in the decision to submit the manuscript for publication. We thank
I. Stalain-Turbiez, MSc, and M. L. Manche-Thevenot, MSc, for editorial assistance
and monitoring of the data. We thank C. Hill, PhD, for her assistance in the
revision of the text. We express sincere gratitude to all women who participated
in the study.