Breast Cancer Clinical Trial

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

Summary

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.

View Full Description

Full Description

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

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
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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

927

Study ID:

NCT06040593

Recruitment Status:

Completed

Sponsor:

Daiichi Sankyo

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

ConcertAI database
Cambridge Massachusetts, 02138, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

927

Study ID:

NCT06040593

Recruitment Status:

Completed

Sponsor:


Daiichi Sankyo

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.