Clinical trial NCT02947061: S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
Official title: S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Recurrent
Keywords: Advanced Breast Cancer,first treatment, S1, Capecitabine
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-10-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 1 year
measure: objective response rate
timeFrame: 2 years
measure: Disease control rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.17 panjiayuannanli, Chaoyang District
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Binghe Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tumor Hospital of Shanxi Province
name: Guohui Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References: