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

NCT06040593 — Completed, 927 participants, Daiichi Sankyo

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

Registry	NCT06040593
Status	Completed
Study type	Observational
Enrollment	927 (Actual)
Sponsor	Daiichi Sankyo (Industry)
Conditions	Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
Interventions	No drug (Other)
Dates	start 2023-07-31, primary completion 2023-11-30, completion 2024-02-23, first posted 2023-09-15, last updated 2024-02-26
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
HR+/HER2-low Breast Cancer		Other: No drug	Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
HR+/HER2-negative Breast Cancer		Other: No drug	Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

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

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
ConcertAI database	Cambridge, Massachusetts	United States