Overview

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

Status:
Completed

Trial end date:
2009-08-01

Target enrollment:
0

Participant gender:
Female

Summary

Determination of guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population of Patients over 70 years old.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jules Bordet Institute

Treatments:

Capecitabine

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-