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Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer.

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer.

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250
mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in
up to 50% of patients leading to those reductions. Some authors have tested continuous
administration schedules of capecitabine, showing better tolerance and apparently similar
antitumor activity. Capecitabine is a pro-drug of 5-FU and mimics an i.v. continuous
infusion administration of this antimetabolite. On the other hand, there are theoretical
reasons to administer S-phase specific agents in continuous, protracted rather than
intermittent schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks
on, one week off)with a continuous administration schule (800 mg/m2/12hr). The latter
schedule administer approximately the same cumulative dose of capecitabine as the standard
one. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced
from 50% (standard arm) to 20% (experimental arm). The investigators assume similar
antitumor activity in both arms.

Inclusion Criteria

Inclusion Criteria

1. Patients diagnosed with metastatic breast cancer

2. Patients that either have received previous treatment with anthracyclines and/or
taxanes or not (either as advance or in metastatic disease).

3. The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).

4. Patient presents, at least one lesion measurable according to RECIST criteria (see
Appendix 3)

5. Patients with a life expectancy of at least 3 months.

6. Patients that agree to and are able to fulfill the requirements of the whole protocol
through the whole study.

Exclusion criteria:

1. Patients that have previously shown unexpected severe reactions to therapy with
fluoropyrimidines or with a known sensitivity to 5-fluorouracile.

2. Patients previously treated with capecitabine.

3. Patients with organ transplants.

4. Other diseases or severe affections:

1. Patients with previous convulsions, central nervous system diseases or
psychiatric diseases, including dementia, that the investigator might consider
clinically significant and which adversely affect therapeutic compliance.

2. Patients with severe intellectual impairment, unable to carry out basic daily
routines and established depression.

3. Clinical significant cardiac disease (e. g. . congestive heart failure,
symptomatic coronary artery disease and cardiac arrhythmia not fully controlled
with medication) or myocardial infarction within the last 12 months.

4. Severe renal impairment (baseline creatinine clearance < 30 ml/min)

5. Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled
convulsions, central nervous system disorders or psychiatric disability judged by the
investigator to be clinically significant precluding informed consent or interfering
with compliance for oral drug intake should be excluded.

6. Patients with an active infection.

7. Patients with a history of other neoplasies during the previous five years, except
for basal cell skin cancer or cervical cancer in situ, both cured.

8. Patients showing the following laboratory values:

1. Neutrophil count < 555 x 109/l

2. Platelet count< 100 x 109/l

3. Serum creatinine > 1,5 x límite superior de normalidad

4. seric bilirubin > 2,0 x límite superior de normalidad

5. ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case
of liver metastases

6. Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit
in case of liver metastases o > 10 x upper normality limit in case of bone

9. Patients under radiotherapy four weeks prior to the initiation of the study
treatment, or under previous radiotherapy on the marker lesions be measured during
the study (new marker lesions that appear in previously irradiated areas are
accepted) or patients who are receiving programmed radiotherapy.

10. Patients under major surgery within 4 weeks prior to study treatment or who have not
completely recovered from the effects of major surgery.

11. Patients who lack upper gastrointestinal tract physical integrity or with
malabsorption syndrome.

12. Patients who have received more than two cycles of chemotherapy for the metastatic

13. Patients Her2 + per FISH ó +++ Inmunohistochemistry

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Outcome Time Frame:


Safety Issue:


Principal Investigator

Miguel Martin, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Clinico San Carlos


Spain: Ministry of Health

Study ID:




Start Date:

September 2005

Completion Date:

December 2011

Related Keywords:

  • Metastatic Breast Cancer
  • capecitabine
  • schedule
  • breast cancer
  • Breast Neoplasms