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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Capecitabine; Docetaxel

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