Clinical trial · Observational
Palbociclib in Real World Practice
POLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY
NCT03280303CI-TRIAL-00080927completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- non-interventional study
- description
- This prospective, observational study will be conducted according to each site's routine clinical practice.
- interventionNames
- Other: non-interventional
Primary outcomes (61)
- measure
- Number of Participants According to Real-World Tumor Response
- timeFrame
- From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
- description
- Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Age ≥18 years or older. 2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent. 3. Documented HR+ (ER+ and/or PR+) tumor based on local standards. 4. Documented HER2- tumor based on local standards. 5. Physician has determined that treatment with palbociclib is indicated. 6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 7. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site. Exclusion Criteria: 1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment. 2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study). 3. Patients on active treatment for malignancies other than ABC at the time of enrollment. 4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent. \-
References
Publications (10)
- DERIVEDTripathy D, Blum JL, Karuturi MS, McCune S, Kurian S, Moezi MM, Anderson DM, Ji Y, Pluard TJ, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Impact of Comorbidities on Clinical Outcomes and Quality of Life of Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer Treated With Palbociclib in the POLARIS Study. Cancer Med. 2026 Apr;15(4):e71788. doi: 10.1002/cam4.71788. PMID 42017805
- DERIVEDTripathy D, Blum JL, McCune S, Pluard T, Anderson D, Johnston A, Montelongo MZ, Zhang Z, Cappelleri JC, Gauthier E, Rocque GB. Real-world effectiveness of palbociclib plus hormone treatment and its impact on patient quality of life: a plain language summary of findings from POLARIS. Future Oncol. 2025 Nov;21(26):3359-3376. doi: 10.1080/14796694.2025.2570468. Epub 2025 Oct 27. PMID 41140056
- DERIVEDRocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Gauthier E, Wang Y, Montelongo MZ, Cappelleri JC, Chen C, Karuturi MS, Tripathy D. Enhancing the interpretation of real-world quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer enrolled in the POLARIS study. Oncologist. 2025 Oct 1;30(10):oyaf281. doi: 10.1093/oncolo/oyaf281. PMID 40971858
- DERIVEDTripathy D, Blum JL, Zhang H, Deng S, McCune SL, Patel K, Wang Y, Lakhanpal S, Karuturi MS, Zhang Z, Deshpande C, Montelongo MZ, Gauthier E, Liu Y, Rocque GB, Bardia A. Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving Palbociclib: Biomarker Results From POLARIS Study. JCO Precis Oncol. 2025 Aug;9:e2400810. doi: 10.1200/PO-24-00810. Epub 2025 Aug 18. PMID 40825169
- DERIVEDRocque GB, Blum JL, Ji Y, Pluard T, Migas J, Lakhanpal S, Jepsen E, Wang Y, Montelongo MZ, Zhang Z, Gauthier E, Tripathy D. Relationship of Prior Anticancer Treatments with Palbociclib Clinical Outcomes in Patients with HR+/HER2- Advanced Breast Cancer in Real-World Settings. Target Oncol. 2025 Jul;20(4):679-692. doi: 10.1007/s11523-025-01158-0. Epub 2025 Jun 24.