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Breast NeoplasmsPhase 2TORCHNCT00527930

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

A Phase 2 study testing TS-1 and Eloxatin in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
TS-1 and Eloxatin
Type of treatment
Injection or infusion
How many people
87 participants
Where
1 siteSouth Korea
Study dates
Sep 2007to Oct 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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))
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  • 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
  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Being tested
TS-1 and Eloxatin
Keywords
Breast Neoplasms, Oxaliplatin, S1
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Measured: TTP, OS

Secondary outcomes (1)

  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)

    Measured: PFS, OS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527930
Sponsor's protocol ID
KCSG-BR-0703, H-0706-009-209
Acronym
TORCH
Status last verified
Oct 2013
First submitted
8 Sep 2007
Last updated
10 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TS-1 and Eloxatin in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: TTP, OS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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