Breast NeoplasmsPhase 4NCT01849380
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
A Phase 4 study testing S-1 and 5-FU in people with Breast Neoplasms and Neoadjuvant Therapy, run by Shandong University at 1 site in China.
Trial summary
S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Neoadjuvant Therapy
- What is being tested?
- S-1 and 5-FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2018
- Phase
- Phase 4
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease characteristic:
- Histologically confirmed primary breast cancer by core biopsy (Mammotome or bard needle)
- Disease stage appropriate for neoadjuvant chemotherapy (T≥3cm, N0 or T（2-3cm）N1 or any T, N2)
- Her-2(-); Ki67≥14%
- No previous treatment for breast cancer (chemotherapy, endocrinotherapy, radiotherapy)
- Patients characteristic:
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- Female patients, age 18 to 70 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy of at least 12 weeks
- Willing to be kept follow-up
- Functions below are maintained in major organs:
- Cardiac status:
- LVEF: 50% 45% • Haematopoietic status: Leukocyte count: ≥4.0×109/L Neutrophil count: ≥2.0×109/L Platelet count: ≥100×109/L Hemoglobin: ≥80g/L
- Hepatic status: Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN(no liver metastasis) bilirubin:
- Renal status: BUN ≤ 1.5 x times ULN Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥50 mL/min; Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
- Written informed consent (both biopsy and neoadjuvant chemotherapy) will be obtained for patients for entering this study
Who cannot join
- Previous treatment for breast cancer (neither local nor systemic therapy)
- Known or suspected distant metastasis
- Potentially pregnant, pregnant, or breast-feeding
- Drug allergy
- Concurrent malignancy or history of other malignancy (except Hodgkin lymphoma)
- Currently active severe infection (Hepatitis included)
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures
- Known history of uncontrolled severe heart disease, myocardial infarction within 6 months, congestive heart failure, unstable angina pectoris, clinically significant hydropericardium or unstable arrhythmias
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Hospital of Shandong Universtity
Jinan, Shandong, 250033
Gang Z Yu, Dr; PhD, +86 0531-85875048, yzg@medmail.com.cn
Gang Z Yu, Dr; PhD
About this study
Official title: Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.
- Conditions
- Breast Neoplasms, Neoadjuvant Therapy
- Being tested
- S-1, 5-FU
- Keywords
- Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called SuLi, QILU Pharmaceutical co.ltd
S-1(SuLi, QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration
5-FUDrug
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin-cyclophosphamide-S-1( ECS) | Experimental | S-1(SuLi,QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration followed by a 14-day rest, combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. Receives: Drug: S-1 |
| Epirubicin-cyclophosphamide-5-FU (ECF) | Active comparator | 5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. Receives: Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla.
Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries.
The primary endpoint will be summarized as pathological complete remission rate for each treatment group.
Ultrasonic examination will be performed every 2 cycles of treatment for efficacy evaluation.
Measured: 12 weeks
Secondary outcomes (2)
Disease-free Survival
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Evaluation will be performed every 2 cycles of treatment during therapy, and follow-up will be performed every 3 months after therapy
Measured: 5 years
Tolerability and safety
Reference to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v 3.0. The endpoint will be summarized as events rate (%) for each treatment group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Zhi Gang, Shandong University
- Investigators
- Gang Z Yu, Dr; PhD, Principal investigator, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849380
- Sponsor's protocol ID
- BEST T-01
- Status last verified
- May 2013
- First submitted
- 6 May 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01849380
- Acronym / sponsor ID
- BEST T-01
- Conditions
- Breast Neoplasms, Neoadjuvant Therapy
- Keywords
- Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 May 2013 (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.
S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epirubicin-cyclophosphamide-S-1( ECS) | Experimental | Drug: S-1S-1(SuLi,QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration followed by a 14-day rest, combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. |
| Epirubicin-cyclophosphamide-5-FU (ECF) | Active comparator | Drug: 5-FU5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Disease characteristic:
- Patients characteristic:
- LVEF: 50% 45% • Haematopoietic status: Leukocyte count: ≥4.0×109/L Neutrophil count: ≥2.0×109/L Platelet count: ≥100×109/L Hemoglobin: ≥80g/L
- Hepatic status: Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN(no liver metastasis) bilirubin:
- Renal status: BUN ≤ 1.5 x times ULN Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥50 mL/min; Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
Key exclusion criteria (8 listed)
- Previous treatment for breast cancer (neither local nor systemic therapy)
- Known or suspected distant metastasis
- Potentially pregnant, pregnant, or breast-feeding
- Drug allergy
- Concurrent malignancy or history of other malignancy (except Hodgkin lymphoma)
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 |
|---|---|---|
| S-1Also: SuLi, QILU Pharmaceutical co.ltdS-1(SuLi, QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration | Drug | Epirubicin-cyclophosphamide-S-1( ECS) |
| 5-FU5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), | Drug | Epirubicin-cyclophosphamide-5-FU (ECF) |
Primary outcome
Pathological complete response
Time frame: 12 weeks
Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla. Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries. The primary endpoint will be summarized as pathological complete remission rate for each treatment group. Ultrasonic examination will be performed every 2 cycles of treatment for efficacy evaluation.
2 secondary outcomes
Disease-free Survival
Time frame: 5 years
Tolerability and safety
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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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.
Gang Z Yu, Dr; PhD principal investigator
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S-1 and 5-FU in people with Breast Neoplasms and Neoadjuvant Therapy, run by Shandong University at 1 site in China.
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 16 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 8 May 2013. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Gang Z Yu, Dr; PhD (+86 0531-85875048, yzg@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 12 weeks). 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 8 May 2013.