Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer

• Conditions: HER2-positive Breast Cancer
• Interventions: Other: RNA sequencing; Other: Transcriptome analysis; Drug: Trastuzumab; Drug: Chemotherapy

• Registration Number: NCT03521245
• Lead Sponsor: OmicsWay Corp.

Brief Summary

The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.

Detailed Description

Biopsy and/or surgical samples from Her2-positive breast cancer patients treated with Trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mRNA sequencing. Expression profiles will be analysed using original bioinformatic platform Oncobox. Based on comparison of molecular pathways activation strength and clinical response to Trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with Trastuzumab and the possibility of further relapse.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-04-28
• Study First Submitted QC: 2018-04-28
• Study First Posted: 2018-05-11
• Primary Completion: 2021-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• adult females
• histologically confirmed HER2-positive breast cancer
• available FFPE samples of breast cancer tissue
• patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1
• stage II or more
• patients who have signed an informed consent

Exclusion Criteria

• less than 70% of intact tumor cells in available FFPE samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab monotherapy	Transcriptome analysis	Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Chemotherapy plus Trastuzumab	Transcriptome analysis	Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Trastuzumab monotherapy	RNA sequencing	Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Chemotherapy plus Trastuzumab	RNA sequencing	Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Chemotherapy plus Trastuzumab	Chemotherapy	Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Chemotherapy plus Trastuzumab	Trastuzumab	Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Trastuzumab monotherapy	Trastuzumab	Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)

Primary Outcome Measures

Name	Time	Method
Tumor response by RECIST v1.1 or pathological response according to Chevallier system	1 year	Tumor response by RECIST v1.1 or pathological response according to Chevallier system

Trial Locations

Locations (4)

OmicsWay Corp.; 🇺🇸 Walnut, California, United States

Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic; 🇷🇺 Petrozavodsk, Karelia Republic, Russian Federation

"Oncobox" Ltd.; 🇷🇺 Moscow, Russian Federation

Vitamed LLC; 🇷🇺 Moscow, Russian Federation