NCT03560856 (PALPETBIO) is a Phase 2 clinical trial of Fulvestrant + palbociclib in Breast Cancer, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT03560856?

NCT03560856 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT03560856?

Interventions in NCT03560856: Fulvestrant + palbociclib.

What condition does NCT03560856 study?

NCT03560856 studies Breast Cancer, HR+/HER2-negative Breast Cancer, Metastasis.

Is NCT03560856 still recruiting?

NCT03560856 is currently status unknown. Last updated 18 June 2018.

Last reviewed 2018-06-18 · How we verify

NCT03560856: PALPETBIO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer

Status unknown Phase 2 Last updated 18 June 2018

What this trial tests

Phase 2 trial testing Fulvestrant + palbociclib in Breast Cancer in 54 participants. Status unknown.

Timeline

27 June 2018

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	27 June 2018
Primary completion	1 June 2022
Estimated completion	1 June 2022

Drugs / interventions tested

Fulvestrant + palbociclib — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
HR+/HER2-negative Breast Cancer — all drugs for HR+/HER2-negative Breast Cancer →
Metastasis — all drugs for Metastasis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, female only, with Breast Cancer or HR+/HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported. In the PALOMA 3 study, the combination of Fulvestrant+ Palbociclib seems to be active in patients whose tumour harbours ESR1 mutations. This study will confirm these data on this population and will allow us to identify if other gene alterations or a genomic signature can correlate with fulvestrant +palbociclib resistance.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
ESR1 mutations and therapeutic resistance in metastatic breast cancer: progress and remaining challenges.
Herzog SK, Fuqua SAW. · · 2022 · cited 117× · PMID 34621045 · DOI 10.1038/s41416-021-01564-x
Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03560856 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 18 June 2018

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/NCT03560856.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing