metastatic breast cancer
Conditions
Interventions
Adapalene is applied to the unilateral of hand and foot daily during capecitabine administration.
Sponsors
Department of gastroenterologic and breast surgery Kanazawa University,School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Scheduled for capecitabine therapy and satisfy the following criteria: 1)Signed informed consent of the patient for the registration. 2)Histological confirmed invasive breast cancer 3)Age: At least 20 years of age 4)ECOG performance status 0 – 2 5)Adequate oral intake 6)Patients without pervious hypersensitive reactions to medicines for external application 7)Expected to survival time: more than 3 months 8)Not received prior chemotherapy with capecitabine 9)Adequate major organ function in the 21 days before entry WBC count 3,000 / mm3 or more( or granulocyte count 1,500 / mm3 or more Platelet 75,000/mm3 or more Hb 9.0g/dl or more AST(GOT) , ALT(GPT),and ALP less than 2.5-times the upper limit of normal (If a patient have liver metastasis, AST(GOT) , ALT(GPT),and ALP less than 5-times the upper limit of normal) Total-bilirubin 1.5 mg/dL or less serum creatinine 1.5 mg/dL or less
Exclusion criteria
Exclusion criteria: 1)Past history of allergic reaction 2)Active secondary malignancies 3)Pregnancy or suspected pregnancy 4)Uncontralled severe infection 5)severe complications (uncontrolled hypertension, angina pectoris, congestive heart disease, liver failure, prior myocardial infarction in less than a year, arrhythmia requiring treatment, or bleeding tendency) 6)Dyspnea requiring oxygen therapy because of interstitial pneumonia or pulmonary fibrosis 7)Symptomatic brain metastasis 8)Uncontrolled diabetes mellitus 9)Severe pleural effusion or ascites 10)Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibition ratio of HFS on the applied hand and foot of adapalene to the opposite sides Inhibiton ratio of HFS: number of cases which have successful treatment with adapalene / number of cases with HFS induced by capecitabine | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with hand-foot syndrome on the applied hand and foot of adapalene or on the opposite side Time to the onset of hand-foot syndrome according to grade of HFS Progression-free Survival (PFS) Overall Response Rate (ORR) Incidence of an adverse event | — |
Countries
Japan
Contacts
Public ContactMasafumi Inokuchi
Kanazawa University Department of gastroenterologic and breast surgery
Outcome results
None listed