Clinical trial · Observational
Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
- 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)
PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Disease Control Rate (DCR) in subjects participating in the clinical investigation [ Time Frame: 2.5 years]
- timeFrame
- 2.5 years
- description
- DCR will be calculated per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.
- measure
- Overall Survival (OS) investigation [ Time Frame: 2.5 years]
- timeFrame
- 2.5 years
- description
- OS will be defined as the elapsed time from the enrolment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will at 1, 2 and 3 months until death or withdrawal of consent from the study.
- measure
- Objective Response Rate (ORR) investigation [ Time Frame: 2.5 years]
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult women and men (≥ 18 years of age) with proven initial diagnosis of breast cancer with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy. 2. Documentation of histologically or cytologically confirmed diagnosis of breast cancer with IHC of estrogen receptor (ER) expression \> 1% and/or progesterone receptor (PR) expression \>1 % breast cancer based on local laboratory results. 3. Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0. 4. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months. 5. Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries). 6. Premenopausal or postmenopausal status. 6.1 Patients who are not postmenopausal must have undergone a treatment with LHRH agonist. 6.2 Postmenopausal status is defined as: 1. prior bilateral surgical oophorectomy, or 2. spontaneous cessation of regular menses for at least 12 consecutive months 3. in case of doubt serum estradiol \<20 umol/l and follicle stimulating hormone (FSH) levels \>15 IU/L. Exclusion Criteria: 1. Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement). 2. Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).
References
Publications (0)
Data not yet available