Phase I/II Study of S-1 plus Cyclophosphamide for Advanced Breast Cancer

JRCT ID: jRCTs031180296

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Unresectable or/and recurrent breast cancer
• Date of first enrollment: 01/12/2007
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Drug: TS-1, Cyclophospamide
TS-1: 80 mg/m2/day po on day 1-14
Cyclophospamide 100 mg/day po on day 15-28

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Overall survival, Progression-free survival, safety

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 75age
• Gender: Both

Include criteria

Cases registered in this study must satisfy all of the following conditions.
1)Have histological confirmation of breast cancer with recurrent and/or metastatic lesion.
2)A phase 1 study:There is no need for measurable lesion. A phase 2 study:Patients who have measurable lesion.
3)Age 20-75
4)The patient must have no carry-over of efficacy from any previous treatment (Surgery: 2 weeks, radiation therapy: 2 weeks, endocrine therapy and trastuzumab: 4 weeks)
5)Performance Status (ECOG Scale) 0-1
6)Patients able to take orally.
7)Body surface area >1.25m2
8)Adequate baseline organ and marrow function as defined below;
Leukocytes:>=3,500/mm3
Absolute neutrophil count:>=2,000/mm3
Platelets:>=100,000/mm3
Hemoglobin:>=9.0 g/dl
AST(GOT):<=(institution's reference value)x2.5
ALT(GPT):<=(institution's reference value)x2.5
Total bilirubin:<=1.5 mg/dl
Serum creatine:<=(institution's reference value)
Creatinine clearance:>=60ml/min (Cockcroft-Gault):female Ccr =body weightx(140-age)/(72xcreatine)x0.85
9) Patients should sign a written informed consent

Exclude criteria

1) Patients with serious complication as followings, (Uncontrolled diabetes mellitus, active infection, severe heart disease (unstable angina, myocardial infarction( within 6 months)), mental disease)
2) Patients with findings of interstitial pneumonia or pulmonary fibrosis by chest X-P.
3) Patients with symptomatic brain metastasis
4) Patients with a history of severe drug hypersensitivity.
5) Active second primary malignancy (except adequately treated carcinoma in situ or malignancy treated more than 5 years ago without recurrence)
6) Women in pregnancy, at risk of pregnancy.
7) During administration of fluoropyrimidines, flucytosine, and pentostatin.
8) Patients who had recurrent disease within one year after administration of fluoropyrimidine or cyclophosphamide based chemotherapy.
9) Patients with previous administration of tegafur / gimeracil/ oteracil.
10) Patients judged inappropriate by physicians

Related Information

• Primary Sponsor: Fujii Takaaki
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO., LTD.,EISAI CO.,LTD.