NCT00717951

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 25, 2008

Status Verified

May 1, 2008

Enrollment Period

1.6 years

First QC Date

July 14, 2008

Last Update Submit

July 24, 2008

Conditions

Advanced Breast Cancer

Keywords

advanced breast cancerdocetaxolcapecitabinecisplatin

Outcome Measures

Primary Outcomes (1)

  • ORR,TTP,TTF and 2 year PFS

    2008-2010

Secondary Outcomes (1)

  • safety and QOL

    2008-2010

Study Arms (2)

A

EXPERIMENTAL

Arm A is "docetaxol+capecitabine" chemotherapy

Drug: docetaxol, cisplatin, capecitabine

B

EXPERIMENTAL

Arm B is "docetaxol+cisplatin" chemotherapy

Drug: docetaxol, cisplatin, capecitabine

Interventions

docetaxol, cisplatin, capecitabineDRUG

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)

AB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34037241DERIVED

  • 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.

    PMID: 33084020DERIVED

MeSH Terms

Interventions

DocetaxelCisplatinCapecitabine

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • jiang zefei, Ph.D

    Academy MMS,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 18, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

July 25, 2008

Record last verified: 2008-05