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

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ClinicalTrials.gov Identifier: NCT02947061
Recruitment Status : Unknown
Verified October 2016 by Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 27, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Binghe Xu, Cancer Institute and Hospital, 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

Condition or disease Intervention/treatment Phase
Breast Cancer Recurrent Drug: S1 plus Docetaxel Drug: Capecitabine plus Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]
  2. objective response rate [ Time Frame: 2 years ]
  3. Disease control rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947061


Contacts
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Contact: Binghe Xu, M.D. 010-87778826
Contact: Jiayu Wang, M.D. 010-87778826

Locations
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China, Beijing
No.17 panjiayuannanli, Chaoyang District Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu, M.D.    86-10-88788826    xubinghe@medmail.com.cn   
Sub-Investigator: Jiayu Wang, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Binghe Xu, M.D. Chinese Academy of Medical Sciences
Principal Investigator: Guohui Han, M.D. Tumor Hospital of Shanxi Province

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Responsible Party: Binghe Xu, Professor and Director, Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02947061     History of Changes
Other Study ID Numbers: CH-BC-033
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Advanced Breast Cancer,first treatment, S1, Capecitabine
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites