Targeted Next Generation Sequencing for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Breast Cancer

NCT03728829 | Unknown

• 1 other identifier: YLiu
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the genetic background of patients with HER2 positive breast cancer that benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically actionable mutations that associated with trastuzumab resistance or drug efficacy, we designed this Observational phase II trial. The primary endpoint is genetic profile of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy. Secondary endpoints included pathological complete response (pCR) rate and safety.

Conditions

Observational; Prospective

Keywords

breast cancer; HER2 positive; next generation sequencing; trastuzumab; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• genetic profile sequenced by a pan-cancer gene panel

  analyze the genetic profile of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy by targeted next generation sequencing on a pan-cancer gene panel

  1 year

Secondary Outcomes (2)

• pCR

  1 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  1 year

Study Arms (1)

Trastuzumab+TP neoadjuvant chemotherapy

100 cases of patients with stage II-III HER2+ breast cancer will be assigned participants to neoadjuvant treatment regimen, including Trastuzumab combined with Docetaxel and Carboplatin. 5-10 ml peripheral blood will be collected from each patient and formalin fixed paraffin embedded (FFPE) blocks/sections or fresh tumor tissues/biopsies will be obtained from the hospitals before and after neoadjuvant therapy. The genomic characteristics between patients achieved pCR and non-pCR will be analyzed. The clinically actionable mutations for future therapy instructions will be identified.

Drug: Trastuzumab+TP

Interventions

Trastuzumab+TP DRUG

Trastuzumab (4 mg/kg loading dose, then 2 mg/kg I.V., every week, totally 17 weeks (6 cycles)) combined with TC neoadjuvant chemotherapy (Docetaxel 75 mg/m2 I.V., day 1, Carboplatin 400 mg/kg, I.V., day 2, every 3 weeks, totally 6 cycles).

Also known as: Trastuzumab+Docetaxel+Carboplatin

Trastuzumab+TP neoadjuvant chemotherapy

Eligibility Criteria

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

Study Population

100

You may qualify if:

• women aged 18-70 years old at the time of diagnosis of primary breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
• Stage III breast cancer according to the 7th Edition of Cancer staging Manual of American Joint Committee on Cancer (AJCC)
• full assessment of ER, PR and HER2 status of primary tumor in accordance with the American Society of Clinical Oncology (ASCO) guidelines
• pathological diagnosis and all courses of treatment confirmed

You may not qualify if:

• any known metastatic disease, by physical exam or by imaging studies such as computed tomography (CT)/magnetic resonance imaging (MRI), at the time of study entry
• any previous exposure to chemotherapy, radiotherapy, or endocrine therapy
• left ventricular ejection fraction (LVEF) \< 55% by Echocardiogram (ECHO) or multigated acquisition scan (MUGA) or significant clinical symptoms or signs of heart failure
• major organ dysfunction, inclusive of bone marrow, renal, liver and hepatic function, that would prohibit patients from receiving standard chemotherapy

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• OrigiMed: collaborator

Study Sites (1)

Fourth Hospital of Hebei Medical University, China

Shijiazhuang, Hebei, 050011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (tissue, whole blood)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Baoen Shan, MD,PhD

  Hebei Medical University Fourth Hospital

  STUDY CHAIR

Central Study Contacts

Yunjiang Liu, MD, PhD

CONTACT

+86-311-8609-5588; lyj818326@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Clinical Professor

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 2, 2018
• Study Start: July 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)