Breast CancerPhase 3NCT00152178
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
A Phase 3 study testing UFT (uracil, tegafur) and tamoxifen and CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen in people with Breast Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- UFT (uracil, tegafur) and tamoxifen and CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteJapan
- Study dates
- Jul 1996to Aug 2008
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 65
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL
- Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
- Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka Medical Center for Cancer and Cardiovascular Diseases
1-1-3, Nakamichi, Higashinari-ku, Osaka, Osaka
About this study
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.
- Conditions
- Breast Cancer
- Being tested
- UFT (uracil, tegafur) and tamoxifen, CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFT (uracil, tegafur) and tamoxifenDrug
UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.
CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifenDrug
CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | UFT (uracil, tegafur) and tamoxifen Receives: Drug: UFT (uracil, tegafur) and tamoxifen |
| 2 | Active comparator | CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen Receives: Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: recurrence and survival will be collected for 5 years after surgery
Secondary outcomes (1)
Overall survival, adverse events, and the quality of life
Measured: adverse events will be collected during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJul 1996
- Primary completionApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hiroki Koyama, MD, Principal investigator, Osaka Medical Center for Cancer and Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152178
- Sponsor's protocol ID
- 91023033
- Status last verified
- Jul 2011
- First submitted
- 8 Sep 2005
- Last updated
- 7 Jul 2011
- Results posted
- No
Publications
Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T. Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study. Br J Cancer. 2009 Aug 18;101(4):598-604. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28.
PubMed 19638976
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
- ClinicalTrials.gov ID
- NCT00152178
- Acronym / sponsor ID
- 91023033
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 1996
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Sep 2005 (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.
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: UFT (uracil, tegafur) and tamoxifenUFT (uracil, tegafur) and tamoxifen |
| 2 | Active comparator | Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifenCMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 65
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL
- Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
- Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| UFT (uracil, tegafur) and tamoxifenUFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years. | Drug | 1 |
| CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifenCMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years. | Drug | 2 |
Primary outcome
Relapse-free survival
Time frame: recurrence and survival will be collected for 5 years after surgery
1 secondary outcome
Overall survival, adverse events, and the quality of life
Time frame: adverse events will be collected during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Results publication: PubMed 19638976Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T. Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study. Br J Cancer. 2009 Aug 18;101(4):598-604. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28.
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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.
Hiroki Koyama, MD principal investigator
Osaka Medical Center for Cancer and Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UFT (uracil, tegafur) and tamoxifen and CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen in people with Breast Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 0 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 7 Jul 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Relapse-free survival (time frame: recurrence and survival will be collected for 5 years after surgery). 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 NCT00152178, which also lists 1 linked publication.
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 7 Jul 2011.