A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer

Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.

The second objective:Assess the safety and QOL.

Study Overview

• Status: Unknown
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: docetaxol, cisplatin, capecitabine

Detailed Description

The study main inclusion criteria are:1.age≥18,KPS>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• age≥18y
• KPS≥ 70
• pathologic diagnosis of breast cancer
• at least 1 measurable lesion as defined by modified RECIST criteria
• screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
• signed ICF
• for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.

Exclusion Criteria:

• More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
• prior exposure to 5-Fluorouracil continuous infusion.
• prior exposure docetaxol for metastatic disease
• Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin

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: A; Arm A is "docetaxol+capecitabine" chemotherapy	Drug: docetaxol, cisplatin, capecitabine; docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)
Experimental: B; Arm B is "docetaxol+cisplatin" chemotherapy	Drug: docetaxol, cisplatin, capecitabine; docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ORR,TTP,TTF and 2 year PFS	2008-2010

Secondary Outcome Measures

Outcome Measure	Time Frame
safety and QOL	2008-2010

Collaborators and Investigators

• Sponsor: Academy Military Medical Science, China
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: jiang zefei, Ph.D, Academy MMS,China

Publications and helpful links

General Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
• Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): July 25, 2008
• Last Update Submitted That Met QC Criteria: July 24, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: cisplatin; capecitabine; advanced breast cancer; docetaxol
• 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; Cisplatin; Capecitabine
• Other Study ID Numbers: TAX625; CBCSG003