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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02947061

Enrollment

300

Registered

2016-10-27

Start date

2015-04-30

Completion date

2019-04-30

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Recurrent

Keywords

Advanced Breast Cancer,first treatment, S1, Capecitabine

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.

Interventions

DRUGS1 plus Docetaxel

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

DRUGCapecitabine plus Docetaxel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	2 years

Secondary

Measure	Time frame
overall survival	1 year
objective response rate	2 years
Disease control rate	2 years

Countries

China

Contacts

Primary ContactBinghe Xu, M.D.

010-87778826

Backup ContactJiayu Wang, M.D.