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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06040593

Collaborator

(none)

925

Enrollment

Location

6.7

Anticipated Duration (Months)

138.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer	Other: No drug

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

925 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy

Actual Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Feb 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: No drug 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.	Other: No drug This is a non-interventional study and no study drug will be provided.

Arm

Intervention/Treatment

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.

Other: No drug

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.

Other: No drug

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

Outcome Measures

Primary Outcome Measures

Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer [Index date to the end of the study period (approximately December 31, 2022)]
Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.
Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer [Index date to the end of the study period (approximately December 31, 2022)]
Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer [Index date to the end of the study period (approximately December 31, 2022)]
Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ConcertAI database	Cambridge	Massachusetts	United States	02138

Sponsors and Collaborators

Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daiichi Sankyo, Inc.

ClinicalTrials.gov Identifier:

NCT06040593

Other Study ID Numbers:

U31402-0005-NIS-EPI

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daiichi Sankyo, Inc.

Hormone-receptor-positive Breast Cancer

HER2-low Breast Cancer

HER2-negative Breast Cancer

Real-world Data

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Sep 15, 2023