Clinical trial · Interventional
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
NCT02947061CI-TRIAL-00024510unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine plus Docetaxel | Drug | — | UNRESOLVED |
| S1 plus Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- test group
- description
- S1 plus Docetaxel :S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
- interventionNames
- Drug: S1 plus Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Capecitabine plus Docetaxel :Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
- interventionNames
- Drug: Capecitabine plus Docetaxel
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.