NCT00527930

Brief Summary

Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and taxane

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

6.1 years

First QC Date

September 8, 2007

Last Update Submit

October 9, 2013

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsOxaliplatinS1

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    TTP, OS

Secondary Outcomes (1)

  • - To determine the time to progression - To determine the response duration - To determine the overall survival - To determine toxicities - To determine the pharmacogenomic predictor (association study)

    PFS, OS

Interventions

TS-1 and EloxatinDRUG

S-1 80 mg/m2/day on day 1-14 Oxaliplatin 130 mg/m2 IV for 2 hour on day 1 Every 3 week Number of Cycles: until progression or unacceptable toxicity

Eligibility Criteria

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

You may qualify if:

  • M/F age ≥ 18
  • Metastatic(TxNxM1) or inoperable locally recurrent breast cancer(rT4NxM0) after taxane \& anthracycline therapy
  • Measurable disease (RECIST) : A patient with at least one measurable lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT
  • No prior treatment with S-1, capecitabine, platinum In metastatic setting
  • Must have received an anthracycline and taxane in adj. or metastatic settings (concurrent, sequential, or combined with other drugs)
  • For taxanes (Paclitaxel (P) / Docetaxel (D))
  • Must have progressed while or after receiving P or D (Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease)
  • Only 1 adjuvant regimen permitted (neoadjuvant immediately followed by surgery and immediately followed by adj. is permitted)
  • For anthracyclines
  • Progressed while on anthracycline treatment, with or without initial response or
  • Have received an adequate course of anthracyclines defined as follows:
  • <!-- -->
  • Adj.: Must have received a standard regimen (doxorubicin ≥ 240 mg/m2 or ≥ 360 mg/m2 epirubicin or equivalent)
  • Metastatic: Must have received a standard regimen(doxorubicin ≥300mg/m2 or equivalent)
  • Not candidate for Herceptin
  • +3 more criteria

You may not qualify if:

  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
  • Informed consent obtained.
  • WOCBP(woman of child bearing potential) unwilling to use acceptable method to avoid pregnancy
  • Breast feeding or pregnant women
  • Patients with Hx of symptomatic brain or leptomeningeal involvement (eligible if asymptomatic 2weeks after proper radiation therapy)
  • ≥grade 3 neuropathy currently
  • Hx of second malignancy except adequately treated basal or squamous skin ca or CIS of cervix. Adequately treated contralateral breast ca with DF \>5 yrs prior to this study is permitted
  • MI, unstable angina, CABG, clinically significant arrhythmia within 6 mo
  • Hx of inflammatory bowel disease or chronic diarrhea,
  • ANC \< 1500, Plt \< 100K, Hb \<9.0
  • Ccr \< 60 ml/min or creatinine \>1.5
  • Bil \> 1.5 x UNL, AST/ALT ≥ 2.5xUNL if hepatic meta + \> 5xUNL)
  • History of hypersensitivity to 5-FU, platinum, or to compounds with similar chemical structures
  • More than 3 prior chemotherapy for metastatic or recurrent disease or prior treatment with S-1, capecitabine or any platinum analogs in metastatic setting (5-FU combine with other agent in metastatic setting is allowed\_ ex) CMF, FAC)
  • Her2(+) pts who are candidates for Herceptin
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

titanium silicideOxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Seock-Ah Im, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2007

First Posted

September 11, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

KR(1)