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

NCT06040593 | Completed

• 1 other identifier: U31402-0005-NIS-EPI
• Study Type: observational
• Target: 927
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hormone-receptor-positive Breast Cancer; HER2-low Breast Cancer; HER2-negative Breast Cancer; Real-world Data

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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

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

Interventions

No drug OTHER

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

HR+/HER2-low Breast Cancer; HR+/HER2-negative Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Patients who received HER2-targeted therapies including
• Trastuzumab
• Pertuzumab
• Ado-trastuzumab emtansine
• Neratinib
• Tucatinib
• Lapatinib
• Fam-trastuzumab deruxtecan-nxki
• Margetuximab

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

ConcertAI database

Cambridge, Massachusetts, 02138, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 15, 2023
• Study Start: July 31, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 23, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)