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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: | NCT00424203 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer Cognitive/Functional Effects Depression Malnutrition Psychosocial Effects of Cancer and Its Treatment |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: cognitive assessment Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ cm [GERICO] |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, nonrandomized, multicenter study.
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires at baseline and after completion of chemotherapy. Questionnaires include the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment (malnutrition), the Folstein Mini-Mental State Exam (cognitive function), the Geriatric Depression Scale (depression), the Cumulative Illness Rating Scale
After completion of study therapy, patients are followed every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the breast
Stage I, II or III disease
Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection
Hormone receptor status:
PATIENT CHARACTERISTICS:
Activities of Daily Living (ADL) score ≥ 5
None of the following at baseline:
No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following:
PRIOR CONCURRENT THERAPY:
France | |
C.H. Senlis | Recruiting |
Senlis, France, 60309 | |
Contact: Elisabeth Carola, MD 33-3-4421-7026 | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Lionel Uwer 33-3-8359-8400 | |
Centre Eugene Marquis | Recruiting |
Rennes, France, 35042 | |
Contact: Brigitte Laguerre 33-2-9925-3000 | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Emmanuel Blot, MD, PhD 33-2-3208-2434 | |
Centre Jean Perrin | Recruiting |
Clermont-Ferrand, France, 63011 | |
Contact: Isabelle Van Praagh, MD 33-4-7327-8103 isabelle.vanpraagh@cjp.fr | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Thomas Bachelot, MD 33-4-78-78-26-54 bachelot@lyon.fnclcc.fr | |
Centre Paul Papin | Recruiting |
Angers, France, 49036 | |
Contact: Sophie Abadie-Lacourtoisie, MD 33-24-135-2734 | |
Centre Regional Rene Gauducheau | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Emmanuelle Bourbouloux, MD 33-2-4067-9974 e-bourbouloux@nantes.fncfcc.fr | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Frederique Rousseau 33-4-9122-3537 | |
Hopital Europeen Georges Pompidou | Recruiting |
Paris, France, 75015 | |
Contact: Eric Levy, MD 33-1-5609-3473 | |
Hopital Perpetuel Secours | Recruiting |
Levallois, France, 92309 | |
Contact: David Giely, MD 33-1-47-59-59-53 d.giely@hndps.com | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Marc Debled, MD 33-5-5633-0477 | |
Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Contact: Loic Mourey, MD 33-5-6142-4174 mourey.loic@claudiusregaud.fr | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Veronique Dieras, MD 33-1-44-32-4675 veronique.dieras@curie.net | |
Institut Jean Godinot | Recruiting |
Reims, France, 51056 | |
Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr | |
Institut Sainte Catherine | Recruiting |
Avignon, France, 84082 | |
Contact: Daniel Serin, MD 33-490-276-263 d.serin@isc84.org | |
Centre Rene Huguenin | Recruiting |
Saint Cloud, France, 92211 | |
Contact: E. G. C. Brain, MD, PhD 33-1-47-111-515 brain@crh1.org |
Study Chair: | E. G. C. Brain, MD, PhD | Centre Rene Huguenin |
Study ID Numbers: | CDR0000523419, FRE-FNCLCC-GERICO-06/0502, EU-20667, EUDRACT-2005-000069-20 |
Study First Received: | January 16, 2007 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00424203 History of Changes |
Health Authority: | Unspecified |
cognitive/functional effects depression malnutrition psychosocial effects of cancer and its treatment stage I breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Depression Immunologic Factors Skin Diseases Adjuvants, Immunologic Breast Neoplasms Quality of Life Cyclophosphamide Depressive Disorder Immunosuppressive Agents Hormones Doxorubicin |
Behavioral Symptoms Anti-Bacterial Agents Malnutrition Mental Disorders Mood Disorders Nutrition Disorders Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Malnutrition Mental Disorders Therapeutic Uses Nutrition Disorders Alkylating Agents Breast Diseases Depression |
Skin Diseases Adjuvants, Immunologic Breast Neoplasms Depressive Disorder Immunosuppressive Agents Doxorubicin Pharmacologic Actions Behavioral Symptoms Neoplasms Myeloablative Agonists Mood Disorders Antineoplastic Agents, Alkylating Antirheumatic Agents |