Clinical trial NCT06040593: Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer
timeFrame: Index date to the end of the study period (approximately December 31, 2022)
measure: Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer
timeFrame: Index date to the end of the study period (approximately December 31, 2022)
measure: Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer
timeFrame: Index date to the end of the study period (approximately December 31, 2022)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: ConcertAI database
state: Massachusetts
Study officials:
References: