Recurrent Breast CancerPhase 2STORMNCT01351597
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
A Phase 2 study testing docetaxel/ oxaliplatin in people with Recurrent Breast Cancer and Metastatic Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Recurrent Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- docetaxel/ oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Sep 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged : 20~70 years
- WHO (ECOG) performance status 0-2
- Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- patients had previously not received chemotherapy of recurrent or metastatic lesion.
- Have given written informed consent and are available for prolonged follow-up
Who cannot join
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression breast cancer
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, 139-707
Sehwan Han, MD. PhD., 82-2-950-1018, hanse@paik.ac.kr
About this study
Official title: An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
Read the detailed description
Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.
- Conditions
- Recurrent Breast Cancer, Metastatic Breast Cancer
- Being tested
- docetaxel/ oxaliplatin
- Keywords
- recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel/ oxaliplatinDrug
Also called Detaxel®, oxalitin®
- docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks
- oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| docetaxel/ oxaliplatin | Experimental | All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion. Receives: Drug: docetaxel/ oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 2 years
Secondary outcomes (3)
progression free survival
Measured: 2 years
toxicity
Measured: 2 years
quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Sehwan Han, MD.PhD., Principal investigator, Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351597
- Sponsor's protocol ID
- KBCSG008
- Acronym
- STORM
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01351597
- Acronym / sponsor ID
- STORM / KBCSG008
- Conditions
- Recurrent Breast Cancer, Metastatic Breast Cancer
- Keywords
- recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
Detailed description
Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel/ oxaliplatin | Experimental | Drug: docetaxel/ oxaliplatinAll the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged : 20~70 years
- WHO (ECOG) performance status 0-2
- Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- patients had previously not received chemotherapy of recurrent or metastatic lesion.
- Have given written informed consent and are available for prolonged follow-up
Key exclusion criteria (8 listed)
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression breast cancer
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel/ oxaliplatinAlso: Detaxel®, oxalitin®1. docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks 2. oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks | Drug | docetaxel/ oxaliplatin |
Primary outcome
overall response rate
Time frame: 2 years
3 secondary outcomes
progression free survival
Time frame: 2 years
toxicity
Time frame: 2 years
quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sehwan Han, MD.PhD. principal investigator
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel/ oxaliplatin in people with Recurrent Breast Cancer and Metastatic Breast Cancer, run by Korean Breast Cancer Study Group 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ku Sang Kim, M.D. (82-31-219-5200, ideakims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2011.