Phase 3
N=195
Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00418028 ↗Enrolled (actual)
195
Serious AEs
8.9%
Results posted
Dec 2017
Primary outcome: Primary: Time to Progression — 8.68; 6.84 months — p=0.1224
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hospital San Carlos, Madrid
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
8.68; 6.84 | 0.1224 |
| SECONDARY Response Rate |
30; 31 | 0.8269 |
| SECONDARY Response Duration |
10.07; 7.20 | 0.5703 |
| SECONDARY Time to Treatment Failure |
5.41; 5.87 | 0.4676 |
| SECONDARY Overall Survival |
27.34; 24.11 | 0.5688 |
| SECONDARY Clinical Benefit |
56; 56 | 0.4984 |
| SECONDARY Progression Free Survival |
8.52; 6.84 | 0.2556 |
Summary
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. There are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter administer approximately the same cumulative dose of capecitabine as the standard schedule. 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.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with metastatic breast cancer
- Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
- The patient is ambulatory with a functional ECOG 1,5 x upper normality limit
- seric bilirubin > 2, 0 x upper normality limit
- ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases
- 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 metastases.
- 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.
- Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
- Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
- Patients who have received more than two cycles of chemotherapy for the metastatic disease.
- Patients Her2 + per FISH ó +++ Immunohistochemistry
Data sourced from ClinicalTrials.gov (NCT00418028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.