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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00527930
• Date of registration: 08/09/2007
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Phase II Trial of Oxaliplatin in Combination With S-1(SOX) in Patients With Recurrent or Metastatic Breast Cancer TORCH
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 87
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00527930
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Seock-Ah Im, MD, PhD
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: TS-1 and Eloxatin

Primary Outcome(s)

Response Rate [Time Frame: TTP, OS]

Secondary Outcome(s)

- 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]

Secondary ID(s)

KCSG-BR-0703, H-0706-009-209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Samsung Medical Center

Asan Medical Center

National Cancer Center, Korea

Korean Cancer Study Group

Seoul National University Bundang Hospital

Severance Hospital