Clinical trial · no report yet · Phase 3
PADA-1
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
- NCT03079011 ↗
- Completed
- UNICANCER
- 122 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| YouTube | 58 | |
| Podcasts | 36 | |
| X threads | 28 |
The trial
ClinicalTrials.gov- Official title
- Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Metastatic Breast Cancer
- Interventions
- Palbociclib 125mg; Aromatase Inhibitors; Fulvestrant Injectable Product
- Arms
- A- palbociclib + AI · Experimental
- B- Palbociclib + fulvestrant · Experimental
- Selection - Palbociclib + AI · Experimental
- Enrollment
- 1,017
- Primary outcomes
- Incidence of treatment-emergent Adverse Events
- Progression-free survival (Step 2)
- Sponsor
- UNICANCER with Pfizer
- Start
- Mar 22, 2017
- Primary completion
- Apr 30, 2021
- Results posted
- No
- Registry record
- NCT03079011 · updated Nov 18, 2025
Publications
linked from the registry- Bidard FC, Hardy-Bessard AC, Dalenc F, Bachelot T, Pierga JY, de la Motte Rouge T, Sabatier R, Dubot C, Frenel JS, Ferrero JM, Ladoire S, Levy C, Mouret-Reynier MA, Lortholary A, Grenier J, Chakiba C, Stefani L, Plaza JE, Clatot F, Teixeira L, D'Hondt V, Vegas H, Derbel O, Garnier-Tixidre C, Canon JL, Pistilli B, Andre F, Arnould L, Pradines A, Bieche I, Callens C, Lemonnier J, Berger F, Delaloge S; PADA-1 investigators. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1367-1377. doi: 10.1016/S1470-2045(22)00555-1. Epub 2022 Sep 29. PubMed 36183733
- Berger F, Marce M, Delaloge S, Hardy-Bessard AC, Bachelot T, Bieche I, Pradines A, De La Motte Rouge T, Canon JL, Andre F, Arnould L, Clatot F, Lemonnier J, Marques S, Bidard FC; PADA-1 investigators. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1. BMJ Open. 2022 Mar 3;12(3):e055821. doi: 10.1136/bmjopen-2021-055821. PubMed 35241469