NCT02947061

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 25, 2016

Last Update Submit

October 27, 2016

Conditions

Breast Cancer Recurrent

Keywords

Advanced Breast Cancer,first treatment, S1, Capecitabine

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2 years

Secondary Outcomes (3)

  • overall survival

    1 year

  • objective response rate

    2 years

  • Disease control rate

    2 years

Study Arms (2)

test group

EXPERIMENTAL

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

Drug: S1 plus Docetaxel

control group

ACTIVE COMPARATOR

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

Drug: Capecitabine plus Docetaxel

Interventions

S1 plus DocetaxelDRUG

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

test group
Capecitabine plus DocetaxelDRUG

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

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.17 panjiayuannanli, Chaoyang District

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

S 1 (combination)DocetaxelCapecitabine

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Binghe Xu, M.D.

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Guohui Han, M.D.

    Tumor Hospital of Shanxi Province

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, M.D.

CONTACT

010-87778826

Jiayu Wang, M.D.

CONTACT

010-87778826

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Department of Medical Oncology

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2019

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)