Breast Cancer ModelPhase 3PERSNCT03006614
PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer
A Phase 3 study testing NVB, EPI and DDP in people with Breast Cancer Model and Effects of Chemotherapy, run by Shi Yanxia at 1 site in China.
Trial summary
This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Model, Effects of Chemotherapy, Breast Cancer
- What is being tested?
- NVB, EPI and DDP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2023
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;
- At the same time to accept any other anti-tumor treatment.
- In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc;
- The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients;
- Active infection (decided by the researchers.
- According to the researcher's judgment, there is serious to endanger the safety of patients, or patients completed the research associated with disease.
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- Pregnancy or breast-feeding women.
- Always have a clear history of neurological or psychiatric disorders, including epilepsy, or dementia.
- A history of other tumors or combined with other tumor patients.
- Before study enrollment for any reason within 30 days of use had not been approved by the local drug ；
- Unwilling or unable to continue to comply with the experimental program, or can not cope with patients follow-up;
- Researchers think that is unfavorable to the participants.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yanxia Shi, doctor, 13609058827, shiyx@sysucc.org.cn
About this study
Official title: Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study
This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
Read the detailed description
This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.
This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.
Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.
- Conditions
- Breast Cancer Model, Effects of Chemotherapy, Breast Cancer
- Being tested
- NVB, EPI, DDP, CAP, GEM
- Keywords
- Breast Cancer Model, Effects of Chemotherapy, 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.
NVBDrug
Also called vinorelbine
EPIDrug
Also called epirubicin
DDPDrug
Also called cisplatin
CAPDrug
Also called capecitabine
GEMDrug
Also called gemcitabine
HDrug
Also called Trastuzumab
CTXDrug
Also called cyclophosphamidem
TDrug
Also called docetaxel
| Study group | Role | What they receive |
|---|---|---|
| PERS:NVB,DDP,GEM,CAP,H etc. | Experimental | vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab Receives: Drug: NVB; Drug: DDP; Drug: CAP; Drug: GEM; Drug: H |
| EPI+CTX-T+/-H | Active comparator | Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w Receives: Drug: EPI; Drug: H; Drug: CTX; Drug: T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
pCR(pathologic complete response)
Measured: up to 96 months
Secondary outcomes (1)
Time as a measure from randomization to disease recurrence or patients died due to disease progression.
DFS(Disease-free survival)
Measured: up to 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ModelStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Yanxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yanxia, Sun Yat-sen University
- Investigators
- YanXia Shi, doctor, Principal investigator, Sun Yat-sen university of cancer center Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006614
- Sponsor's protocol ID
- 2014-FXY-077-内科
- Acronym
- PERS
- Status last verified
- Jan 2017
- First submitted
- 28 Apr 2016
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT03006614
- Acronym / sponsor ID
- PERS / 2014-FXY-077-内科
- Conditions
- Breast Cancer Model, Effects of Chemotherapy, Breast Cancer
- Keywords
- Breast Cancer Model, Effects of Chemotherapy, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shi YanxiaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Dec 2016 (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 study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
Detailed description
This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.
This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.
Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERS:NVB,DDP,GEM,CAP,H etc. | Experimental | Drug: NVB, Drug: DDP, Drug: CAP, Drug: GEM, Drug: Hvinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab |
| EPI+CTX-T+/-H | Active comparator | Drug: EPI, Drug: H, Drug: CTX, Drug: TEpirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;
- At the same time to accept any other anti-tumor treatment.
- In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc;
- The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients;
- Active infection (decided by the researchers.
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 |
|---|---|---|
| NVBAlso: vinorelbine | Drug | PERS:NVB,DDP,GEM,CAP,H etc. |
| EPIAlso: epirubicin | Drug | EPI+CTX-T+/-H |
| DDPAlso: cisplatin | Drug | PERS:NVB,DDP,GEM,CAP,H etc. |
| CAPAlso: capecitabine | Drug | PERS:NVB,DDP,GEM,CAP,H etc. |
| GEMAlso: gemcitabine | Drug | PERS:NVB,DDP,GEM,CAP,H etc. |
| HAlso: Trastuzumab | Drug | EPI+CTX-T+/-H, PERS:NVB,DDP,GEM,CAP,H etc. |
| CTXAlso: cyclophosphamidem | Drug | EPI+CTX-T+/-H |
| TAlso: docetaxel | Drug | EPI+CTX-T+/-H |
Primary outcome
Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
Time frame: up to 96 months
pCR(pathologic complete response)
1 secondary outcome
Time as a measure from randomization to disease recurrence or patients died due to disease progression.
Time frame: up to 96 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Individual participant dataSharing planned: No
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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.
YanXia Shi, doctor principal investigator
Sun Yat-sen university of cancer center Recruiting
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 NVB, EPI and DDP in people with Breast Cancer Model and Effects of Chemotherapy, run by Shi Yanxia 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 0 inclusion and 12 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 16 Jan 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YanXia Shi, doctor (02087343488, shiyanxia@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination. (time frame: up to 96 months). 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 16 Jan 2017.