Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

927 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-02-23

Brief Summary

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There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.

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Detailed Description

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This retrospective, non-interventional study is designed to assess the following primary objectives:

1. To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and
2. To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.

Conditions

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Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HR+/HER2-low Breast Cancer

Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

HR+/HER2-negative Breast Cancer

Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be provided.

Interventions

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No drug

This is a non-interventional study and no study drug will be provided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis)
* Stage I-IIIB at the time of diagnosis
* Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy
* Received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or IO therapy)

Exclusion Criteria

* Patients who received HER2-targeted therapies including

* Trastuzumab
* Pertuzumab
* Ado-trastuzumab emtansine
* Neratinib
* Tucatinib
* Lapatinib
* Fam-trastuzumab deruxtecan-nxki
* Margetuximab

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No