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

Chemotherapy Effect Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03359694
• Other study ID #: NO20170819
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 20, 2017
• Last updated: November 27, 2017
• Start date: December 2017
• Est. completion date: October 2022

Study information

• Verified date: November 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Sheng Zhang, Doctor
• Phone: +86 23340123
• Email: 403826461[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2022
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy Effect
• Disease Susceptibility
• Genetic Predisposition to Disease
• Susceptibility, Genetic

Intervention

Drug:
• DT group
Pegylated liposomal doxorubicin 30mg/m2,iv,d1, Docetaxel 75mg/m2,iv,d1, q21d×6
• ET group
Conventional doxorubicin 75mg/m2,iv,d1, Docetaxel 75mg/m2,iv,d1, q21d×6
• NX group
Navelbine IVD 25 mg/m2 D1?D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d

Locations

Country	Name	City	State
China	Jin Zhang	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR rate	pCR rate in the DT and ET group	2 years
Secondary	Efficacy of neo-adjuvant chemotherapy	5-year DFS in the DT and ET group	5 years
Secondary	Efficacy of sequential chemotherapy	5-year DFS of non- pCR patients treated by sequential NX regimen	6 years