Clinical trial · Observational
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-low Breast Cancer | HER2-Low Breast Carcinoma | ALIAS | 0.90 |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drug | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HR+/HER2-low Breast Cancer
- description
- Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
- interventionNames
- Other: No drug
- label
- HR+/HER2-negative Breast Cancer
- description
- Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
- interventionNames
- Other: No drug
Primary outcomes (3)
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available