Phase 2
Completed N=41
Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00534417 ↗Enrolled (actual)
41
Serious AEs
22.0%
Results posted
Feb 2013
Primary outcomePrimary: Time to Progression (TTP) — 26.94 Months
Summary
The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
26.94 | — |
| PRIMARY Progression-free Survival (PFS) |
14.98 | — |
| SECONDARY Best Overall Response |
2; 8; 28; 3 | — |
| SECONDARY Overall Response Rate |
24.4 | — |
| SECONDARY Clinical Benefit Rate |
58.5 | — |
| SECONDARY Patients Experiencing Severe Symptom Burden (Physical Symptoms) |
3.3; 3.3; 10.0; 26.7; 10.0; 6.7 | — |
| SECONDARY Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) |
10.3; 6.9; 10.3; 3.4; 3.4; 10.3 | — |
| SECONDARY Patients Experiencing Severe Symptom Burden (Physical Functioning) |
37.0; 7.1; 10.7; 10.7; 25.9; 14.3 | — |
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- At least 18 years of age.
- Post-menopausal female (ie, amenorrheic for at least 12 months prior to study entry). Post-menopausal status will be confirmed by drawing follicle stimulating hormone (FSH) and estradiol levels if 1.5 x 109/L; Platelet count > 100 x 109/L.
- Renal function: estimated creatinine clearance > 30 mL/min as calculated with Cockcroft-Gault equation.
- Note: In patients with moderate renal impairment (calculated creatinine clearance 30 to 50 mL/min) at baseline, a dose reduction to (-1) of the capecitabine starting dose is required.
- Serum bilirubin 1.5 × upper normal limit (ULN).
- Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 × ULN (or >5 × ULN in the case of liver metastases).
- Alkaline phosphatase > 2.5 × ULN (or >5 × ULN in the case of liver metastases or >10 × ULN in the case of bone disease).
- International normalization ratio (INR) >1.6.
- History of:
- Bleeding diathesis, (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
- Long-term anticoagulant therapy, (other than antiplatelet therapy and warfarin 1 mg qd for port prophylaxis).
- History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol).
- Unwillingness to give written informed consent.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT00534417). 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. Informational only — not medical advice.