Breast CancerPhase 3NCT00152191
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
A Phase 3 study testing UFT (uracil, tegafur) and cyclophosphamide, methotrexate, and fluorouracil in people with Breast Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- UFT (uracil, tegafur) and cyclophosphamide, methotrexate, and fluorouracil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteJapan
- Study dates
- Oct 1996to Jan 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75
- Performance status 0 or 1 (ECOG)
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
- Renal Creatinine ≤ ULN
Who cannot join
- Prior anticancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
- Conditions
- Breast Cancer
- Being tested
- UFT (uracil, tegafur), cyclophosphamide, methotrexate, and fluorouracil
- 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)Drug
uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
cyclophosphamide, methotrexate, and fluorouracilDrug
cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | UFT (uracil, tegafur) Receives: Drug: UFT (uracil, tegafur) |
| 2 | Active comparator | CMF(cyclophosphamide, methotrexate, and fluorouracil) Receives: Drug: cyclophosphamide, methotrexate, and fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: every course for first three courses, then every other course
Secondary outcomes (1)
Overall survival, adverse events, and the quality of life
Measured: any time
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 startOct 1996
- Primary completionOct 2007
- Study completionJan 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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Toru Watanabe, MD, Principal investigator, Hamamatsu Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152191
- Sponsor's protocol ID
- 01023001
- Status last verified
- Jul 2011
- First submitted
- 7 Sep 2005
- Last updated
- 7 Jul 2011
- Results posted
- No
Publications
Watanabe T, Sano M, Takashima S, Kitaya T, Tokuda Y, Yoshimoto M, Kohno N, Nakagami K, Iwata H, Shimozuma K, Sonoo H, Tsuda H, Sakamoto G, Ohashi Y. Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial. J Clin Oncol. 2009 Mar 20;27(9):1368-74. doi: 10.1200/JCO.2008.18.3939. Epub 2009 Feb 9.
PubMed 19204202
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
- A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)
- ClinicalTrials.gov ID
- NCT00152191
- Acronym / sponsor ID
- 01023001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 1996
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 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 is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of 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)UFT (uracil, tegafur) |
| 2 | Active comparator | Drug: cyclophosphamide, methotrexate, and fluorouracilCMF(cyclophosphamide, methotrexate, and fluorouracil) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75
- Performance status 0 or 1 (ECOG)
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
- Renal Creatinine ≤ ULN
Key exclusion criteria (1 listed)
- Prior anticancer treatment
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)uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years | Drug | 1 |
| cyclophosphamide, methotrexate, and fluorouracilcyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8 | Drug | 2 |
Primary outcome
Relapse-free survival
Time frame: every course for first three courses, then every other course
1 secondary outcome
Overall survival, adverse events, and the quality of life
Time frame: any time
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 19204202Watanabe T, Sano M, Takashima S, Kitaya T, Tokuda Y, Yoshimoto M, Kohno N, Nakagami K, Iwata H, Shimozuma K, Sonoo H, Tsuda H, Sakamoto G, Ohashi Y. Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial. J Clin Oncol. 2009 Mar 20;27(9):1368-74. doi: 10.1200/JCO.2008.18.3939. Epub 2009 Feb 9.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Toru Watanabe, MD principal investigator
Hamamatsu Oncology Center
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 cyclophosphamide, methotrexate, and fluorouracil 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 5 inclusion and 1 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: every course for first three courses, then every other course). 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 NCT00152191, 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.