Breast NeoplasmsPhase 2NCT00438100
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
A Phase 2 study testing Capecitabine and S-1 in people with Breast Neoplasms, run by Japan Breast Cancer Research Network at 8 sites in Japan.
Trial summary
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 25 to 74 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Capecitabine and S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2008to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-diagnosed breast cancer with metastasis in multiple organs
- Performance Status (World Health Organization :WHO) 0-2
- Functions below are maintained in major organs:
- Leukocyte count: 4,000/mm3 to 12,000/mm3
- Neutrophil count: >2,000/mm3 or more
- Platelet count: <100,000/mm3 or more
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- Hemoglobin: >9.5 g/dL
- Total bilirubin: >1.5 mg/dL
- AST(GOT): within twice a normal upper value in an institution
- AST(GPT): within twice a normal upper value in an institution
- BUN: < 25 mg/dL
- Creatinine: within a normal upper value in the institution
- 24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)
- Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
- Written informed consent will be obtained for patients for entering this study
Who cannot join
- Patients with synchronous multiple cancers
- Complicated with infection
- Fever from suspected infection
- Metastasis to the central nerve system
- A history of ischemic cardiac diseases
- Active gastrointestinal ulcer
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- Severe nerve disorder
- Women who are potentially pregnant, pregnant, or breast-feeding
- Severe drug allergy
- Severe suppression of the bone marrow
- Severe renal disorder
- Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
- Being treated with flucytosine
- Complicated with the infection onset which a study doctor assesses to be inappropriate for this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Kyushu Central Hospital
Fukuoka, 815-8588
Kansai Medical University Hirakata Hospital
Hirakata, 573-1191
Hirosaki University Hospital
Hirosaki, 036-8563
Hiroshima University Hospital
Hiroshima, 734-8551
Shinyahashiradai Hospital
Matsudo, 270-2253
Seiko Hospital
Neyagawa, Osaka, 572-0831
The University of Tokyo Hospital
Tokyo, 113-8655
Nagumo Clinic
Tokyo, 141-0032
About this study
Official title: Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Read the detailed description
The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with breast cancer in 2001, making it the leading cause of cancer among women since 1995. Statistical database in Exel format/outline of health welfare statistics from the Ministry of Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in 2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast cancer patients, detection and treatment at an earlier stage can lead to higher survival rates. However, the recurrence rate increases as the disease progresses. In addition, about thirty percent of all breast cancer patients are believed to have recurrent disease. Thus, developing treatments against recurrence may be an important task.
The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B recommendation) breast cancer. In a second-line therapy recommended for metastatic or recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is superior to docetaxel alone for improving survival. This regimen is recommended for patients with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation). However, data are lacking to support capecitabine as a standard regimen as a second-line therapy; its efficacy needs verification and further study. Accordingly, this study is designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride, to which an indication of "inoperable or recurrent breast cancer" was added, as a first-line therapy in patients with inoperable or recurrent breast cancer by comparing it with Capecitabine alone, which is already approved of the same indication.
- Conditions
- Breast Neoplasms
- Being tested
- Capecitabine, S-1
- Keywords
- Breast Neoplasms, Drug Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
S-1Drug
Also called TS-1
80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine arm | Active comparator | Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. Receives: Drug: Capecitabine |
| S-1 arm | Experimental | S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course. Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: The follow up period will be two years after the last dose has been administered.
Secondary outcomes (4)
Adverse Events
Measured: The follow up period will be two years after the last dose has been administered.
Antitumor Effects
Measured: The follow up period will be two years after the last dose has been administered.
Time to Treatment Failure
Measured: The follow up period will be two years after the last dose has been administered.
Survival Rate
Measured: The follow up period will be two years after the last dose has been administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startApr 2008
- Primary completionJul 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Breast Cancer Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daigo Yamamoto, MD, Principal investigator, Department of Surgery, Kansai Medical University Hirakata Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438100
- Sponsor's protocol ID
- JBCRN-05
- Other IDs
- UMIN000000609
- Status last verified
- May 2015
- First submitted
- 18 Feb 2007
- Last updated
- 29 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00438100
- Acronym / sponsor ID
- JBCRN-05
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Japan Breast Cancer Research NetworkUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Detailed description
The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with breast cancer in 2001, making it the leading cause of cancer among women since 1995. Statistical database in Exel format/outline of health welfare statistics from the Ministry of Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in 2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast cancer patients, detection and treatment at an earlier stage can lead to higher survival rates. However, the recurrence rate increases as the disease progresses. In addition, about thirty percent of all breast cancer patients are believed to have recurrent disease. Thus, developing treatments against recurrence may be an important task.
The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B recommendation) breast cancer. In a second-line therapy recommended for metastatic or recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is superior to docetaxel alone for improving survival. This regimen is recommended for patients with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation). However, data are lacking to support capecitabine as a standard regimen as a second-line therapy; its efficacy needs verification and further study. Accordingly, this study is designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride, to which an indication of "inoperable or recurrent breast cancer" was added, as a first-line therapy in patients with inoperable or recurrent breast cancer by comparing it with Capecitabine alone, which is already approved of the same indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine arm | Active comparator | Drug: CapecitabineCapecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. |
| S-1 arm | Experimental | Drug: S-1S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy-diagnosed breast cancer with metastasis in multiple organs
- Performance Status (World Health Organization :WHO) 0-2
- Functions below are maintained in major organs:
- Written informed consent will be obtained for patients for entering this study
Key exclusion criteria (14 listed)
- Patients with synchronous multiple cancers
- Complicated with infection
- Fever from suspected infection
- Metastasis to the central nerve system
- A history of ischemic cardiac diseases
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 |
|---|---|---|
| CapecitabineAlso: Xeloda1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. | Drug | Capecitabine arm |
| S-1Also: TS-180 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course. | Drug | S-1 arm |
Primary outcome
Progression Free Survival
Time frame: The follow up period will be two years after the last dose has been administered.
4 secondary outcomes
Adverse Events
Time frame: The follow up period will be two years after the last dose has been administered.
Antitumor Effects
Time frame: The follow up period will be two years after the last dose has been administered.
Time to Treatment Failure
Time frame: The follow up period will be two years after the last dose has been administered.
Survival Rate
Time frame: The follow up period will be two years after the last dose has been administered.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daigo Yamamoto, MD principal investigator
Department of Surgery, Kansai Medical University Hirakata Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and S-1 in people with Breast Neoplasms, run by Japan Breast Cancer Research Network at 8 sites in Japan.
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 15 inclusion and 14 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: The follow up period will be two years after the last dose has been administered.). 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 29 May 2015.