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

Phase 2
70 Years
Not Enrolling
Elderly Patients, Breast Cancer

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Trial Information

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

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

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

- 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

6. absence of

- symptomatic ventricular arrhythmias;

- clinically significant Congestive Heart Failure;

- clinical and/or ECG evidence of myocardial infarction within the last 12

- 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:


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety of capecitabine in ederly

Outcome Description:

safety of capecitabine in ederly

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Chantal Bernard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

Elderly capecitabine 1



Start Date:

January 2003

Completion Date:

August 2009

Related Keywords:

  • Elderly Patients
  • Breast Cancer
  • Breast Neoplasms