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NCT06607601
CARE Initiative: Real-world Emulation of the PALOMA-2 Trial
trial testing Palbociclib in Metastatic Breast Cancer in 724 participants. Completed in 20 July 2023.
20 July 2023
Quick facts
| Lead sponsor | Aetion, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 724 |
| Start date | 1 February 2010 |
| Primary completion | 20 July 2023 |
| Estimated completion | 20 July 2023 |
Drugs / interventions tested
- Palbociclib (Palbociclib) — full drug profile →
- Letrozole — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Aetion, Inc. — full company profile →
Who can join
18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. The main questions this study aims to answer are: 1. Do patients with metastatic ER+/HER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival (rwPFS) compared with patients treated with letrozole alone? 2. How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06607601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Palbociclib
Trials testing the same drug.
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- NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
- NCT06997029 — A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors · Phase 1 · recruiting
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other Aetion, Inc. trials
Trials by the same sponsor.
- NCT05908799 — Emulation of the KEYNOTE-189 Trial Using Electronic Health Records · completed
- NCT05638932 — Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments · completed
- NCT04926571 — Dexamethasone and COVID-19 Inpatient Mortality · completed
- NCT06607393 — CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3] · completed
- NCT06585189 — CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4] · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06607601 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aetion, Inc.
- Last refreshed: 23 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06607601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing