Clinical trial NCT03359694: Mutation Scores and Differential Protein Evaluating Efficacy in Adjuvant Chemotherapy in HER2(-) Luminal B Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Susceptibility, Genetic
Chemotherapy Effect
Keywords: breast cancer, neoadjuvant chemotherapy,susceptible gene
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pCR rate
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of neo-adjuvant chemotherapy
timeFrame: 5 years
measure: Efficacy of sequential chemotherapy
timeFrame: 6 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Jin Zhang
Study officials:
affiliation: Tianjin Medical University Cancer Institure and Hospital
name: Jin Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: