Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer

NCT ID: NCT03359694

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2022-10-31

Brief 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 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.

Conditions

Susceptibility, Genetic; Chemotherapy Effect

Keywords

breast cancer, neoadjuvant chemotherapy,susceptible gene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DT group

Pegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

Group Type: EXPERIMENTAL

DT group

Intervention Type: DRUG

Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

ET group

Conventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

Group Type: ACTIVE_COMPARATOR

ET group

Intervention Type: DRUG

Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

NX group

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

Group Type: EXPERIMENTAL

NX group

Intervention Type: DRUG

Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d

Control group

no treatment group of Non-pCR patients after DT or ET neoadjuvant chemotherapy.

No drugs treatment in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DT group

Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

Intervention Type: DRUG

ET group

Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6

Intervention Type: DRUG

NX group

Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d

Intervention Type: DRUG

Other Intervention Names

Pegylated liposomal doxorubicin and Docetaxel; Conventional doxorubicin and Docetaxel; Navelbine and Xeloda

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institure and Hospital

Locations

Jin Zhang

Tianjin, , China

Countries

China

Central Contacts

Sheng Zhang, Doctor

Role: CONTACT

Phone: +86 23340123

Email: 403826461@qq.com

Other Identifiers

NO20170819

Identifier Type: -

Identifier Source: org_study_id