Breast CancerPhase 2NCT01492543
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
A Phase 2 study testing Tegafur Gimeracil Oteracil Potassium Capsule in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 7 sites in China.
Trial summary
The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer. 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?
- Tegafur Gimeracil Oteracil Potassium Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesChina
- Study dates
- Dec 2011to Oct 2014
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old female.
- ECOG status: 0-2.
- Life expectancy of ≥ 3 months.
- Histologic or cytologic diagnosis of breast cancer.
- Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
- At least one measurable lesion of >=2 cm (>=1 cm on spiral CT scan)according to RECIST (v1.1).
Show all 12Show fewer
- Adequate organ functions:
- Hematopoietic: Hemoglobin ≥90g/L, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥80×10^9/L.
- Biochemistry: TBil ≤1.5 times upper limit of normal (ULN), AST and ALT ≤2.5× ULN(≤5x ULN if due to liver metastases), Creatinine ≤1.0×ULN and Creatinine clearance >50 ml/min.
- Women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered.
- Ability to take oral medication .
- Signed informed consent.
Who cannot join
- Pregnancy or lactation or no effective contraception in fertile patients.
- Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
- Less than 4 weeks since prior investigational agents.
- conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
- Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
- CNS or psychiatric disorders.
Show all 15Show fewer
- Allergic to 5-FU.
- Only with bone metastases and no measurable lesions.
- Clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment.
- Serious peptic ulcer disease or digestive disorders.
- Bone marrow (Hemoglobin <90g/dl, ANC <1.5×10^9/L, Platelet count <75×10^9/L).
- Renal function disorder (Creatinine >1.0×ULN).
- Liver function disorder (TBil >1.5×ULN).
- Uncontrolled brain metastases.
- Noncompliance with the study protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
Dan Yu, MD, +86-13810292522, xiaoyugw@126.com
Hong Dai, MD
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Donggui Wan, MD, +86-13601365686, dongguiwan@263.net
Donggui Wan, MD
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100036
Lijun Di, MD, +86-8819-6406, Dilijun2012@gmail.com
Lijun Di, MD
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Huihui Rao, MD, +86-15110047147, 15110047147@163.com
Junlan Yang, MD
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Peng Yuan, MD, 86-10-8778-8114, yuanpeng01@hotmail.com
Binghe Xu, MD, PhD
- Recruiting
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, 050019
Long Wang, MD, +86-13803343508, 125662333@qq.com
Wei Liu, MD
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhongsheng Tong, MD, +86-13920458207, tonghang@medmail.com
Zhongsheng Tong, MD
About this study
Official title: An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.
Read the detailed description
Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.
- Conditions
- Breast Cancer
- Being tested
- Tegafur Gimeracil Oteracil Potassium Capsule
- Keywords
- Advanced, Metastatic, Breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegafur Gimeracil Oteracil Potassium CapsuleDrug
Also called TS-1
Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,
| Study group | Role | What they receive |
|---|---|---|
| Aiyi® | Experimental | Tegafur Gimeracil Oteracil Potassium Capsule Receives: Drug: Tegafur Gimeracil Oteracil Potassium Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Up to 2 years
Secondary outcomes (2)
Clinical response rate
Assessed by RECIST v1.1 criteria.
Measured: Every six weeks
Adverse events
Measured: Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Chinese PLA General Hospital, China-Japan Friendship Hospital, Tianjin Medical University Cancer Institute and Hospital, Hebei Tumor Hospital
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, MD, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492543
- Sponsor's protocol ID
- CH-BC-014
- Status last verified
- Mar 2013
- First submitted
- 12 Dec 2011
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01492543
- Acronym / sponsor ID
- CH-BC-014
- Conditions
- Breast Cancer
- Keywords
- Advanced, Metastatic, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Chinese PLA General Hospital, China-Japan Friendship Hospital, Tianjin Medical University Cancer Institute and Hospital, Hebei Tumor Hospital
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 15 Dec 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 assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.
Detailed description
Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aiyi® | Experimental | Drug: Tegafur Gimeracil Oteracil Potassium CapsuleTegafur Gimeracil Oteracil Potassium Capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18-75 years old female.
- ECOG status: 0-2.
- Life expectancy of ≥ 3 months.
- Histologic or cytologic diagnosis of breast cancer.
- Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
Key exclusion criteria (15 listed)
- Pregnancy or lactation or no effective contraception in fertile patients.
- Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
- Less than 4 weeks since prior investigational agents.
- conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
- Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
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 |
|---|---|---|
| Tegafur Gimeracil Oteracil Potassium CapsuleAlso: TS-1Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd., | Drug | Aiyi® |
Primary outcome
Progression-free survival
Time frame: Up to 2 years
2 secondary outcomes
Clinical response rate
Time frame: Every six weeks
Adverse events
Time frame: Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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.
Binghe Xu, MD, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
7 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 Tegafur Gimeracil Oteracil Potassium Capsule in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 7 sites 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 12 inclusion and 15 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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 Peng Yuan, MD (86-10-8778-8114, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to 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 15 Mar 2013.