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

HER2-negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040593
• Other study ID #: U31402-0005-NIS-EPI
• Status: Completed
• Start date: July 31, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 927
• Est. completion date: February 23, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-negative Breast Cancer

Intervention

Other:
• No drug
This is a non-interventional study and no study drug will be provided.

Locations

Country	Name	City	State
United States	ConcertAI database	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)