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

NCT ID: NCT02947061

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Recurrent

Keywords

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Advanced Breast Cancer,first treatment, S1, Capecitabine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

S1 plus Docetaxel

Intervention Type DRUG

S1 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 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1

Group Type ACTIVE_COMPARATOR

Capecitabine plus Docetaxel

Intervention Type DRUG

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

Interventions

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S1 plus Docetaxel

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

Intervention Type DRUG

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Binghe Xu

Professor and Director, Department of Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Binghe Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Guohui Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tumor Hospital of Shanxi Province

Locations

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No.17 panjiayuannanli, Chaoyang District

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binghe Xu, M.D.

Role: CONTACT

Phone: 010-87778826

Jiayu Wang, M.D.

Role: CONTACT

Phone: 010-87778826

Facility Contacts

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Binghe Xu, M.D.

Role: primary

Other Identifiers

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CH-BC-033

Identifier Type: -

Identifier Source: org_study_id