Clinical trial · Observational
HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving CDK4/6i + Aromatase Inhibitor (AI) Combination Therapy as Initial Endocrine-based Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was prematurely discontinued due to significant data quality issues on August 26, 2021. There were no safety concerns that led to the decision to terminate.
Summary
Brief summary (as posted)
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A
Primary outcomes (17)
- measure
- Number of Participants With Different Type of Treatment Regimens
- timeFrame
- From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
- description
- Treatment regimen was defined as one or more anti-cancer agents given in combination, over a period of time.
- measure
- Number of Participants Who Received Different Treatment Sequence Across Lines
- timeFrame
- From start to end of treatment, for a maximum of 33 months (during 15 months of retrospective observation period)
- description
- Lines of therapy was defined as the following progression-based lines, in which a disease progression must occur for a new regimen to be interpreted as a new line of therapy. Disease progression was taken to have occurred when a pathology report or radiological scan indicated disease progression and/or there was a physician progress note consistent with that determination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female or male sex. 2. Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis. 3. Age ≥18 years at A/MBC diagnosis. 4. Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019. •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval. 5. Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present). 6. Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present). Exclusion Criteria: 1\. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
References
Publications (0)
Data not yet available