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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-04-30

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

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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.

Conditions

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Breast Cancer Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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test group

S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Group Type EXPERIMENTAL

S1 plus Docetaxel

Intervention Type DRUG

S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

control group

Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Group Type ACTIVE_COMPARATOR

Capecitabine plus Docetaxel

Intervention Type DRUG

Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Interventions

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S1 plus Docetaxel

S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Intervention Type DRUG

Capecitabine plus Docetaxel

Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No