Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study
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Purpose
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 |
|---|---|---|
|
Elderly Patients Breast Cancer |
Drug: Adjuvant capecitabine Drug: capecitabine in aduvant setting |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study |
- safety of capecitabine in ederly [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]safety of capecitabine in ederly
| Enrollment: | 43 |
| Study Start Date: | January 2003 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: capecitabine
capecitabine 2000 mg/m² daily
|
Drug: Adjuvant capecitabine
Capecitabine 2000 mg/m² daily six cycles
Other Name: Xeloda
Drug: capecitabine in aduvant setting
capecitabine in aduvant setting in ederly with breast cancer
Other Name: Xeloda
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women aged ³70 years
Histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. Recommended situations are for example:
- endocrine non responsive (ER- and PgR -) and pT>1 cm, any T if N+ OR
- endocrine responsiveness doubtful (ER and/or PgR- or poor [3 to-5 according to Harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pT³2 cm or N+ or G3 or Her-2/neu positive, etc.) OR
- endocrine responsive (ER and PgR > 5 according to Harvey score or > 30% of positive cells by immunohistochemistry) and at least two risk factors (pT³ 2 cm, N+, G3, Her-2/neu positive, etc.) OR
- Very high risk (N>3) any ER/PgR.
- ECOG Performance status £ 1
- No previous exposition to chemotherapy in the neoadjuvant setting
Adequate organ function including:
- neutrophils ³ 1.5 x 109 /l
- platelets ³100 x 109 / l
- bilirubin < 1.25 x upper normal limit for the institution
- transaminases < 2.5 x upper normal limit for the institution
- calculated creatinine clearance of > 30ml/min (using the Crockoft and Gault formula)
absence of
- symptomatic ventricular arrhythmias;
- clinically significant Congestive Heart Failure;
- clinical and/or ECG evidence of myocardial infarction within the last 12 months;
- Coronary artery disease requiring medication.
- Absence of any psychological, familial or sociological condition or comorbidities that may affect compliance
- Written informed consent obtained according to local ethics committee guidelines -
Exclusion Criteria:
N/A-
Contacts and Locations More Information
No publications provided
| Responsible Party: | Chantal Bernard, Institut Jules Bordet |
| ClinicalTrials.gov Identifier: | NCT00263705 History of Changes |
| Other Study ID Numbers: | Elderly capecitabine 1 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Capecitabine Fluorouracil Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 21, 2013