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

NCT03359694 | Unknown Phase 3

• 1 other identifier: NO20170819
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Susceptibility, Genetic; Chemotherapy Effect

Keywords

breast cancer, neoadjuvant chemotherapy,susceptible gene

Outcome Measures

Primary Outcomes (1)

• pCR rate

  pCR rate in the DT and ET group

  2 years

Secondary Outcomes (2)

• Efficacy of neo-adjuvant chemotherapy

  5 years

• Efficacy of sequential chemotherapy

  6 years

Study Arms (4)

DT group

EXPERIMENTAL

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

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

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

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.

Interventions

DT group DRUG

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

Also known as: Pegylated liposomal doxorubicin and Docetaxel

DT group

ET group DRUG

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

Also known as: Conventional doxorubicin and Docetaxel

ET group

NX group DRUG

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

Also known as: Navelbine and Xeloda

NX group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Jin Zhang

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease; Breast Neoplasms

Interventions

liposomal doxorubicin; Docetaxel; Vinorelbine; Capecitabine

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jin Zhang, Doctor

  Tianjin Medical University Cancer Institure and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Zhang, Doctor

CONTACT

+86 23340123; 403826461@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 2, 2017
• Study Start: December 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: October 1, 2022
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)