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

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ClinicalTrials.gov Identifier: NCT03728829
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yunjiang Liu, Hebei Medical University Fourth Hospital

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.

Condition or disease Intervention/treatment
Observational Prospective Drug: Trastuzumab+TP

Detailed Description:

Currently, patients with stage II-III breast cancer still accounts for a large population in China, and neoadjuvant therapy is considered the standard treatment for them. The pathological complete response (pCR) rate takes for an indicator for regimens efficacy, and the achievement of pCR after neoadjuvant chemotherapy is associated with favorable outcomes including disease-free survival and overall survival.

HER2+ breast cancer represents an invasive and poor prognosis subtype, and the efficacy of neoadjuvant therapy for these patients has been greatly augmented by the addition of trastuzumab. However, more than 50% of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy cannot achieve pCR, even experience primary drug resistance and rapid disease progression. Therefore, to explore the genomic features of the population that benefited from trastuzumab combined with chemotherapy is of great significance for personalized treatment of HER2+ breast cancer, aiming to avoid overtreatment and identify clinically actionable mutations for future therapy instructions.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Phase II Trial of Targeted Next Generation Sequencing Analysis for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Patients With HER2 Positive Breast Cancer
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
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).
Other Name: Trastuzumab+Docetaxel+Carboplatin




Primary Outcome Measures :
  1. genetic profile sequenced by a pan-cancer gene panel [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. pCR [ Time Frame: 1 year ]
    The pathological complete response (pCR) rate of patients treated with trastuzumab neoadjuvant chemotherapy.

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 year ]
    The incidence of adverse events of patients treated with trastuzumab neoadjuvant chemotherapy, including Cardiac toxicity, leukopenia, etc.


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)


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728829


Contacts
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Contact: Yunjiang Liu, MD, PhD +86-311-8609-5588 lyj818326@126.com

Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Study Chair: Baoen Shan, MD,PhD Hebei Medical University Fourth Hospital

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Responsible Party: Yunjiang Liu, Vice President, Clinical Professor, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03728829     History of Changes
Other Study ID Numbers: YLiu
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yunjiang Liu, Hebei Medical University Fourth Hospital:
breast cancer
HER2 positive
next generation sequencing
trastuzumab
neoadjuvant chemotherapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological