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

Phase 2

• Conditions: Breast Cancer Recurrent
• Interventions: Drug: S1 plus Docetaxel; Drug: Capecitabine plus Docetaxel

• Registration Number: NCT02947061
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31
• Primary Completion: 2017-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	S1 plus Docetaxel	S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
control group	Capecitabine plus Docetaxel	Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Primary Outcome Measures

Name	Time	Method
progression free survival	2 years

Secondary Outcome Measures

Name	Time	Method
objective response rate	2 years
overall survival	1 year
Disease control rate	2 years

Trial Locations

Locations (1)

No.17 panjiayuannanli, Chaoyang District; 🇨🇳 Beijing, Beijing, China