NCT03809988 (PALMIRA) is a Phase 2 clinical trial of Palbociclib in Breast Cancer, sponsored by MedSIR.

Who is sponsoring NCT03809988?

NCT03809988 is sponsored by MedSIR.

What drugs are being tested in NCT03809988?

Interventions in NCT03809988: Palbociclib, Endocrine therapy.

What condition does NCT03809988 study?

NCT03809988 studies Breast Cancer, Advanced Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast.

Is NCT03809988 still recruiting?

NCT03809988 is currently completed. Last updated 7 September 2023.

Last reviewed 2023-09-07 · How we verify

NCT03809988: PALMIRA

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

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

Completed Phase 2 Last updated 7 September 2023

What this trial tests

Phase 2 trial testing Palbociclib in Breast Cancer in 198 participants. Completed in 30 November 2022.

Timeline

5 April 2019

Primary endpoint
30 November 2022

30 November 2022

Quick facts

Lead sponsor	MedSIR
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	198
Start date	5 April 2019
Primary completion	30 November 2022
Estimated completion	30 November 2022
Sites	53 locations across France, Italy, United Kingdom, Germany, Slovenia, Spain

Drugs / interventions tested

Palbociclib (Palbociclib) — full drug profile →
Endocrine therapy (endocrine-therapy) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Advanced Breast Cancer — all drugs for Advanced Breast Cancer →
Hormone Receptor Positive Tumor — all drugs for Hormone Receptor Positive Tumor →
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast — all drugs for Human Epidermal Growth Factor 2 Negative Carcinoma of Breast →

Sponsor

MedSIR — full company profile →

Who can join

18 and older, female only, with Breast Cancer or Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

Publications & conference data

8 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
Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR+/HER2- Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1).
Bardia A, Hurvitz SA, DeMichele A, Clark AS, et al · · 2021 · cited 101× · PMID 33722897 · DOI 10.1158/1078-0432.ccr-20-2114
High p16 expression and heterozygous RB1 loss are biomarkers for CDK4/6 inhibitor resistance in ER+ breast cancer.
Palafox M, Monserrat L, Bellet M, Villacampa G, et al · · 2022 · cited 91× · PMID 36071033 · DOI 10.1038/s41467-022-32828-6
CDK4/6 Inhibitor Treatments in Patients with Hormone Receptor Positive, Her2 Negative Advanced Breast Cancer: Potential Molecular Mechanisms, Clinical Implications and Future Perspectives.
Roberto M, Astone A, Botticelli A, Carbognin L, et al · · 2021 · cited 47× · PMID 33477469 · DOI 10.3390/cancers13020332
Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial.
Albanell J, Pérez-García JM, Gil-Gil M, Curigliano G, et al · · 2023 · cited 34× · PMID 36165912 · DOI 10.1158/1078-0432.ccr-22-1281
Filling the Gap after CDK4/6 Inhibitors: Novel Endocrine and Biologic Treatment Options for Metastatic Hormone Receptor Positive Breast Cancer.
Mittal A, Molto Valiente C, Tamimi F, Schlam I, et al · · 2023 · cited 32× · PMID 37046675 · DOI 10.3390/cancers15072015
Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial.
Llombart-Cussac A, Harper-Wynne C, Perelló A, Hennequin A, et al · · 2025 · cited 20× · PMID 40294349 · DOI 10.1200/jco-24-01865
CDK4/6 Inhibitors-Overcoming Endocrine Resistance Is the Standard in Patients with Hormone Receptor-Positive Breast Cancer.
Nabieva N, Fasching PA. · · 2023 · cited 20× · PMID 36980649 · DOI 10.3390/cancers15061763

Verify or expand the search:

Other trials of Palbociclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
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 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 MedSIR trials

Trials by the same sponsor.

NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed

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 NCT03809988 (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 MedSIR
Last refreshed: 7 September 2023

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/NCT03809988.

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