S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer

Study Overview
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Brief Summary
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To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment

Detailed Description
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To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.

Official Title
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S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study

Conditions
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Breast Cancer Recurrent

Intervention / Treatment
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* Drug: S1 plus Docetaxel
* Drug: Capecitabine plus Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 ≤ age ≤ 75; ECOG 0-2, The expected survival time more than 3 months; Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer; No chemical treatment after Cancer recurrence; At least one measurable disease ( as per RECIST1.1); Adequate bone marrow functions (ANC ≥1.5×109 /L, PLT ≥100×109 /L, HB ≥90 g/L); Adequate renal functions(serum creatinine ≤ 1.5 ULN; creatinine clearance≥50 ml/min); liver functions (serum bilirubin ≤ 1.5ULN, AST/ALT ≤ 2.5 ULN); Written informed consent; Pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception. Exclusion Criteria: Previously chemotherapy with cytotoxic drugs Pregnant, lactating women Did not take effective contraceptive measures Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence; Her-2 positive or unknown Other trails Before 4weeks Affection of the absorption of drugs(Unable to swallow、after gastrectomy、Chronic diarrhea and intestinal obstruction Organs with rapid progression of invasion(Liver and lung lesions more than 1/2 organ area or hepatic insufficiency) Central nervous system disorders or mental disorders For docetaxel or fluorouracil or Twain 80 had serious adverse reactions or Allergy to 5-FU Severe upper gastrointestinal ulcer or absorption dysfunction syndrome Abnormal blood routine (ANC <1.5×109 /L, PLT <100×109 /L, HB <90 g/L); Renal functions(serum creatinine > 1.5 ULN); Liver functions (serum bilirubin > 1.5ULN Brain metastases out of control Other unapplicable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 | Drug: S1 plus Docetaxel<br>* S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1<br>|
| Active Comparator: control group<br>Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1 | Drug: Capecitabine plus Docetaxel<br>* Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year | 
| objective response rate |  | 2 years | 
| Disease control rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Breast Cancer,first treatment, S1, Capecitabine