S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
Primary Purpose
Breast Cancer Recurrent
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S1 plus Docetaxel
Capecitabine plus Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Recurrent focused on measuring Advanced Breast Cancer,first treatment, S1, Capecitabine
Eligibility 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
Sites / Locations
- No.17 panjiayuannanli, Chaoyang DistrictRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
test group
control group
Arm 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
Capecitabine plus Docetaxel :Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival
objective response rate
Disease control rate
Full Information
NCT ID
NCT02947061
First Posted
October 25, 2016
Last Updated
October 27, 2016
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02947061
Brief Title
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
Official Title
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Recurrent
Keywords
Advanced Breast Cancer,first treatment, S1, Capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm 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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
S1 plus Docetaxel
Intervention Description
S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
Intervention Type
Drug
Intervention Name(s)
Capecitabine plus Docetaxel
Intervention Description
Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Title
objective response rate
Time Frame
2 years
Title
Disease control rate
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghe Xu, M.D.
Phone
010-87778826
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayu Wang, M.D.
Phone
010-87778826
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guohui Han, M.D.
Organizational Affiliation
Tumor Hospital of Shanxi Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.17 panjiayuannanli, Chaoyang District
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
Phone
86-10-88788826
Email
xubinghe@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Jiayu Wang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
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