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

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

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.

Study Overview

• Status: Completed
• Conditions: HER2-negative Breast Cancer; HER2-low Breast Cancer; Hormone-receptor-positive Breast Cancer
• Intervention / Treatment: Other: No drug

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 927

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • ConcertAI database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 and treated with neoadjuvant chemotherapy or endocrine therapy will be identified from the ConcertAI database based on the inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer	Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.	Index date to the end of the study period (approximately December 31, 2022)
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	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.	Index date to the end of the study period (approximately December 31, 2022)

Collaborators and Investigators

• Sponsor: Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HER2-negative Breast Cancer; Real-world Data; Hormone-receptor-positive Breast Cancer; HER2-low Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: U31402-0005-NIS-EPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No