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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00629616 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.
PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: fulvestrant Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Multicenter Phase II Study Identifying Hormonosensivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-Adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women. |
Estimated Enrollment: | 116 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients in both arms then undergo surgery and radiotherapy according to institutional guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years.
After completion of study therapy, patients are followed periodically for up to 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed infiltrating breast adenocarcinoma
Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
No uncontrolled cardiac pathology, including any of the following:
PRIOR CONCURRENT THERAPY:
France | |
Centre Eugene Marquis | Recruiting |
Rennes, France, 35042 | |
Contact: Contact Person 33-2-9925-3000 | |
Centre Jean Perrin | Recruiting |
Clermont-Ferrand, France, 63011 | |
Contact: Contact Person 33-73-278-080 | |
Centre Paul Strauss | Recruiting |
Strasbourg, France, 67065 | |
Contact: Contact Person 33-3-8825-2424 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Contact Person 33-1-4211-4339 | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Contact Person 33-44-32-4000 | |
Centre Rene Huguenin | Recruiting |
Saint Cloud, France, 92211 | |
Contact: Contact Person 33-147-111-529 m.tubiana@stcloud-huguenin.org |
Investigator: | Michelle Tubiana-Hulin, MD | Centre Rene Huguenin |
Study ID Numbers: | CDR0000585501, FNCLCC-CARMINA-02/0609, EU-20805, FNCLCC-NIMFEA, ZENECA-FNCLCC-CARMINA-02-0609 |
Study First Received: | March 5, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00629616 |
Health Authority: | Unspecified |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Naphazoline Oxymetazoline Anastrozole Skin Diseases Guaifenesin |
Phenylephrine Fulvestrant Breast Neoplasms Phenylpropanolamine Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |