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Sponsored by: |
Jules Bordet Institute |
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Information provided by: | Jules Bordet Institute |
ClinicalTrials.gov Identifier: | NCT00263705 |
Determination of guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population of Patients over 70 years old.
Condition | Intervention | Phase |
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Elderly Patients Breast Cancer |
Drug: Adjuvant capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study |
Estimated Enrollment: | 43 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2005 |
Patients over 70 years old are under represented in clinical trials and there are no clear guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population. Whether CT retains the benefit conferred to younger patients remains uncertain. Moreover, there is extensive data regarding the increasing incidence and severity of side effects, such as myelotoxicity, mucositis and cardiotoxicity, with CT in this population. The efficacy and safety of CT in aged patients have been evaluated in different studies, most of them in haematological malignancy. Clearly, the patients’ functional declines with age and the risk for CT toxicity rises with age. There is no standard of care regarding adjuvant chemotherapy for breast cancer in patients older than 70 years old.
This is a pilot study evaluating the feasibility and safety of 6 cycles of capecitabine in patients aged 70 years or more with high-risk early invasive breast cancer who have undergone optimal surgery.
The primary end point is to evaluate the possibility of delivering 6 cycles of capecitabine at the dose of 1000 mg/m² BID days 1 to 14 every 3 weeks, in terms of rate of patients who will receive an acceptable relative dose intensity (RDI).
Secondary end points are safety (including the evaluation of possible impact of treatment on the functional, cognitive and emotional status of the patient) and evaluating if some form of geriatric assessment add any information to the classic “inclusion criteria screening” in terms of prediction of treatment compliance and toxicity.
The study is being conducted at the Jules Bordet Institute. The planned accrual is 43 patients.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. Recommended situations are for example:
Adequate organ function including:
absence of
Exclusion Criteria:
N/A-
Contact: Chantal Bernard, MD | chantal.bernard@bordet.be |
Belgium | |
Jules Bordet Institute | Recruiting |
Brussels, Belgium, 1000 | |
Contact: Chantal Bernard, MD chantal.bernard@bordet.be | |
Principal Investigator: Chantal Bernard, MD |
Principal Investigator: | Chantal Bernard, MD | Jules Bordet Institute |
Study ID Numbers: | Elderly capecitabine 1 |
Study First Received: | September 13, 2005 |
Last Updated: | December 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00263705 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Capecitabine Skin Diseases Breast Neoplasms Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |