Phase II Trial of Oxaliplatin in Combination With S-1(SOX) in Patients With Recurrent or Metastatic Breast Cancer (TORCH)

October 9, 2013 updated by: Seock-Ah Im, Seoul National University Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main purpose of this study is to find out the efficacy and safety profile of TS-1 with oxaliplatin in previously anthracycline and taxane pretreated patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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))

    1. 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)
    2. Only 1 adjuvant regimen permitted (neoadjuvant immediately followed by surgery and immediately followed by adj. is permitted)

  • For anthracyclines

    1. Progressed while on anthracycline treatment, with or without initial response or
    2. Have received an adequate course of anthracyclines defined as follows:
    1. Adj.: Must have received a standard regimen (doxorubicin ≥ 240 mg/m2 or ≥ 360 mg/m2 epirubicin or equivalent)
    2. Metastatic: Must have received a standard regimen(doxorubicin ≥300mg/m2 or equivalent)
  • Not candidate for Herceptin
  • ECOG PS ≤ 2
  • Completion of all prior chemotherapy ≥ 3 wks prior to enrol
  • Completion of hormonal therapy 2 wks prior to enroll
  • Resolution of all clinically significant toxic effects (excluding alopecia and sensory neuropathies) of any prior surgery or therapy to grade ≤ 1 (NCI CTCAE 3.0), for peripheral neuropathy grade ≤ 2 (NCI CTCAE 3.0), or to within the limits listed in the specific inclusion/exclusion criteria
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
  • Informed consent obtained.

Exclusion Criteria:

  • 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
  • prior surgery within 4 week
  • participate in other clinical trials within 4 week
  • prior radiation therapy within 2 week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Response Rate
Time Frame: TTP, OS
TTP, OS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
- 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)
Time Frame: PFS, OS
PFS, OS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Center, Korea
Samsung Medical Center
Asan Medical Center
Seoul National University Bundang Hospital
Severance Hospital
Korean Cancer Study Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seock-Ah Im, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KCSG-BR-0703, H-0706-009-209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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