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

Phase 3

• Conditions: Susceptibility, Genetic; Chemotherapy Effect
• Interventions: Drug: DT group; Drug: ET group; Drug: NX group

• Registration Number: NCT03359694
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Study Start: 2017-12
• Study First Posted: 2017-12-02
• Last Update Posted: 2017-12-02
• Primary Completion: 2019-11
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DT group	DT group	Pegylated liposomal doxorubicin and Docetaxel Treatment group Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
ET group	ET group	Conventional doxorubicin and Docetaxel Treatment group Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
NX group	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

Primary Outcome Measures

Name	Time	Method
pCR rate	2 years	pCR rate in the DT and ET group

Secondary Outcome Measures

Name	Time	Method
Efficacy of neo-adjuvant chemotherapy	5 years	5-year DFS in the DT and ET group
Efficacy of sequential chemotherapy	6 years	5-year DFS of non- pCR patients treated by sequential NX regimen

Trial Locations

Locations (1)

Jin Zhang; 🇨🇳 Tianjin, China