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

To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Recurrent
• Intervention / Treatment: Drug: S1 plus Docetaxel; Drug: Capecitabine plus Docetaxel

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • No.17 panjiayuannanli, Chaoyang District
      • Contact: Binghe Xu, M.D.; Phone Number: 86-10-88788826; Email: xubinghe@medmail.com.cn
      • Sub-Investigator: Jiayu Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; 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; S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
Active Comparator: control group; 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; Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression free survival	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Guohui Han, M.D., Tumor Hospital of Shanxi Province

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Advanced Breast Cancer,first treatment, S1, Capecitabine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine
• Other Study ID Numbers: CH-BC-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO