Clinical trial · Observational
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
- 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 is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
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- metastatic breast cancer patients in the US.
Primary outcomes (31)
- measure
- Number of Participants According to Year of Initial Diagnosis of Breast Cancer
- timeFrame
- Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
- description
- Number of participants according to their year of initial diagnosis of breast cancer were reported.
- measure
- Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
- timeFrame
- Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
- description
- AJCC stages included: stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), and unknown. T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 =2-5 cm, T3 = greater than (\>) 2 cm, T4 = large sized, N0 = not spread to lymph node (LN), N1 = spread to LN 1 to 3, N2= spread to LN 4 to 9, N3 = spread \>10 axillary LN, M0 = no metastasis, M1= metastasis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Diagnosed with locoregional recurrent or metastatic female breast cancer.
2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:
1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
5. ≥18 year old at initiation of palbociclib.
Exclusion Criteria:
* No exclusion criteria will be imposed for the selection of patients.References
Publications (0)
Data not yet available