Susceptibility, GeneticPhase 3NCT03359694
Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer
A Phase 3 study testing DT group, ET group and NX group in people with Susceptibility, Genetic and Chemotherapy Effect, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Susceptibility, Genetic, Chemotherapy Effect
- What is being tested?
- DT group, ET group and NX group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2017to Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Compliance with test procedures and good compliance
- Females, Age more than 18 years of age, less than 70 years old
- The ECOG score is 0-1
- Primary invasive cancer, T2-4bN0-2M0 breast cancers
- Neoadjuvant chemotherapy with standard 6 courses should be completed
Show all 10Show fewer
- Patients must undergo standard breast cancer surgery after neoadjuvant chemotherapy
- Luminal B, Her2 negative patients
- No other malignant tumors occurred at the same time
- adequate liver and kidney function
Who cannot join
- Any metastasis
- Suffered other maligant tumors
- Participate in other trials
- Accompanied with severe systemic disease and / or uncontrollable infection
- Pregnant and lactating women
- Dysfunction of liver and kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mutation Scores and Differential Protein Evaluating Efficacy in Neo-adjuvant Chemotherapy and the Non-PCR Patients Treated With Sequential Nalvelbine and Xeloda in HER2(-) Luminal B Breast Cancer
We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
Read the detailed description
This is a prospective, randomized, open phase III clinical trial which will be sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of Pegylated Liposomal Doxorubicin and Docetaxel (DT) Compared to Conventional Doxorubicin and Docetaxel (ET) regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant Nalvelbine and Xeloda (NX) regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
- Conditions
- Susceptibility, Genetic, Chemotherapy Effect
- Being tested
- DT group, ET group, NX group
- Keywords
- breast cancer, neoadjuvant chemotherapy,susceptible gene
- Medical subject headings
- Genetic Predisposition to Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT groupDrug
Also called Pegylated liposomal doxorubicin and Docetaxel
Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
ET groupDrug
Also called Conventional doxorubicin and Docetaxel
Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
NX groupDrug
Also called Navelbine and Xeloda
Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d
| Study group | Role | What they receive |
|---|---|---|
| DT group | Experimental | Pegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 Receives: Drug: DT group |
| ET group | Active comparator | Conventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 Receives: Drug: ET group |
| NX group | Experimental | Navelbine and Xeloda treatment group in group of Non-pCR patients Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d×4 Receives: Drug: NX group |
| Control group | No intervention | no treatment group of Non-pCR patients after DT or ET neoadjuvant chemotherapy. No drugs treatment in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pCR rate in the DT and ET group
Measured: 2 years
Secondary outcomes (2)
Efficacy of neo-adjuvant chemotherapy
5-year DFS in the DT and ET group
Measured: 5 years
Efficacy of sequential chemotherapy
5-year DFS of non- pCR patients treated by sequential NX regimen
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Susceptibility, GeneticStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Zhang, Doctor, Principal investigator, Tianjin Medical University Cancer Institure and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359694
- Sponsor's protocol ID
- NO20170819
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutation Scores and Differential Protein Evaluating Efficacy in Neo-adjuvant Chemotherapy and the Non-PCR Patients Treated With Sequential Nalvelbine and Xeloda in HER2(-) Luminal B Breast Cancer
- ClinicalTrials.gov ID
- NCT03359694
- Acronym / sponsor ID
- NO20170819
- Conditions
- Susceptibility, Genetic, Chemotherapy Effect
- Keywords
- breast cancer, neoadjuvant chemotherapy,susceptible gene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 2 Dec 2017 (actual)
- 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.
We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
Detailed description
This is a prospective, randomized, open phase III clinical trial which will be sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of Pegylated Liposomal Doxorubicin and Docetaxel (DT) Compared to Conventional Doxorubicin and Docetaxel (ET) regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant Nalvelbine and Xeloda (NX) regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DT group | Experimental | Drug: DT groupPegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 |
| ET group | Active comparator | Drug: ET groupConventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 |
| NX group | Experimental | Drug: NX groupNavelbine and Xeloda treatment group in group of Non-pCR patients Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d×4 |
| Control group | No intervention | –no treatment group of Non-pCR patients after DT or ET neoadjuvant chemotherapy. No drugs treatment in this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form
- Compliance with test procedures and good compliance
- Females, Age more than 18 years of age, less than 70 years old
- The ECOG score is 0-1
- Primary invasive cancer, T2-4bN0-2M0 breast cancers
Key exclusion criteria (6 listed)
- Any metastasis
- Suffered other maligant tumors
- Participate in other trials
- Accompanied with severe systemic disease and / or uncontrollable infection
- Pregnant and lactating women
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 |
|---|---|---|
| DT groupAlso: Pegylated liposomal doxorubicin and DocetaxelPegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 | Drug | DT group |
| ET groupAlso: Conventional doxorubicin and DocetaxelConventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6 | Drug | ET group |
| NX groupAlso: Navelbine and XelodaNavelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d | Drug | NX group |
Primary outcome
pCR rate
Time frame: 2 years
pCR rate in the DT and ET group
2 secondary outcomes
Efficacy of neo-adjuvant chemotherapy
Time frame: 5 years
Efficacy of sequential chemotherapy
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Jin Zhang, Doctor principal investigator
Tianjin Medical University Cancer Institure and Hospital
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 DT group, ET group and NX group in people with Susceptibility, Genetic and Chemotherapy Effect, run by Tianjin Medical University Cancer Institute and Hospital 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 10 inclusion and 6 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 2 Dec 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 Sheng Zhang, Doctor (+86 23340123 ext. 2111, 403826461@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 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 2 Dec 2017.