NCT04483505: ROGABREAST

Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.

Completed Phase 1 Last updated 28 December 2023

What this trial tests

Phase 1 trial testing Combination, Rogaratinib + palbociclib + fulvestrant in Breast Cancer Metastatic in 9 participants. Completed in 4 April 2023.

Timeline

25 November 2020

Primary endpoint
4 April 2023

4 April 2023

Quick facts

Lead sponsor	Fundacion CRIS de Investigación para Vencer el Cáncer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	9
Start date	25 November 2020
Primary completion	4 April 2023
Estimated completion	4 April 2023
Sites	8 locations across Spain

Drugs / interventions tested

• Combination, Rogaratinib + palbociclib + fulvestrant — full drug profile →

Conditions studied

• Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →
• Hormone Receptor Positive Malignant Neoplasm of Breast — all drugs for Hormone Receptor Positive Malignant Neoplasm of Breast →

Sponsor

Fundacion CRIS de Investigación para Vencer el Cáncer — full company profile →

Who can join

18 and older, female only, with Breast Cancer Metastatic or Hormone Receptor Positive Malignant Neoplasm of Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open, multicenter, prospective phase I dose escalation clinical trial followed by an expansion cohort. The aim of this study is to asses the Recommended Phase 2 Dose (R2PD) and the safety profile, among other efficacy, in FGFR1/2/3 positive, hormone receptor-positive breast cancer (HRPBC) patients with metastatic disease after progression to the combination of an aromatase inhibitor plus palbociclib, abemaciclib or ribociclib, according RECIST 1.1 criteria.

Publications & conference data

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

1. Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
   Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
2. 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
3. Targeting Angiogenesis in Breast Cancer: Current Evidence and Future Perspectives of Novel Anti-Angiogenic Approaches.
   Ayoub NM, Jaradat SK, Al-Shami KM, Alkhalifa AE. · · 2022 · cited 83× · PMID 35281942 · DOI 10.3389/fphar.2022.838133
4. Tyrosine Kinase Receptors in Oncology.
   Esteban-Villarrubia J, Soto-Castillo JJ, Pozas J, San Román-Gil M, et al · · 2020 · cited 72× · PMID 33198314 · DOI 10.3390/ijms21228529
5. Biological Significance and Targeting of the FGFR Axis in Cancer.
   Chioni AM, Grose RP. · · 2021 · cited 45× · PMID 34830836 · DOI 10.3390/cancers13225681
6. Targeting Aberrant FGFR Signaling to Overcome CDK4/6 Inhibitor Resistance in Breast Cancer.
   Sobhani N, Fassl A, Mondani G, Generali D, et al · · 2021 · cited 42× · PMID 33535617 · DOI 10.3390/cells10020293
7. FGFR1 amplification or overexpression and hormonal resistance in luminal breast cancer: rationale for a triple blockade of ER, CDK4/6, and FGFR1.
   Mouron S, Manso L, Caleiras E, Rodriguez-Peralto JL, et al · · 2021 · cited 38× · PMID 33579347 · DOI 10.1186/s13058-021-01398-8
8. FGFR signaling and endocrine resistance in breast cancer: Challenges for the clinical development of FGFR inhibitors.
   Servetto A, Formisano L, Arteaga CL. · · 2021 · cited 33× · PMID 34303787 · DOI 10.1016/j.bbcan.2021.188595