Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study

This study has been completed.
Sponsor:
Information provided by:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT00263705
First received: September 13, 2005
Last updated: February 23, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Women aged ³70 years
  2. 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.
  3. ECOG Performance status £ 1
  4. No previous exposition to chemotherapy in the neoadjuvant setting
  5. Adequate organ function including:

    1. neutrophils ³ 1.5 x 109 /l
    2. platelets ³100 x 109 / l
    3. bilirubin < 1.25 x upper normal limit for the institution
    4. transaminases < 2.5 x upper normal limit for the institution
    5. calculated creatinine clearance of > 30ml/min (using the Crockoft and Gault formula)
    6. 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.
  6. Absence of any psychological, familial or sociological condition or comorbidities that may affect compliance
  7. Written informed consent obtained according to local ethics committee guidelines -

Exclusion Criteria:

N/A-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263705

Locations
Belgium
Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Chantal Bernard, MD Jules Bordet Institute
  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: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014