Skip to main content
OpenTrials
Completed

NCT Number: NCT06040593

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ConcertAI database

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No drug

Other

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

Primary outcomes

  1. Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer

    Time frame: 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.

  2. Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer

    Time frame: Index date to the end of the study period (approximately December 31, 2022)

  3. Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.