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

Breast Cancer Recurrent Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02947061
• Other study ID #: CH-BC-033
• Status: Recruiting
• Phase: Phase 2
• First received: October 25, 2016
• Last updated: October 27, 2016
• Start date: April 2015
• Est. completion date: April 2019

Study information

• Verified date: October 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Binghe Xu, M.D.
• Phone: 010-87778826
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Recurrent
• Breast Neoplasms

Intervention

Drug:
• S1 plus Docetaxel
S1 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

Locations

Country	Name	City	State
China	No.17 panjiayuannanli, Chaoyang District	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		2 years	No
Secondary	overall survival		1 year	No
Secondary	objective response rate		2 years	No
Secondary	Disease control rate		2 years	No