Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Palbociclib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients will receive rogaratinib, palbociclib and fulvestrant in cycles of 28 days.

Escalation Dose will follow a classic 3+3 schedule.The planned dose-levels are as follows:

* Level 1: Rogaratinib 400 mg PO BID + standard fulvestrant 500 mg every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 3 patients).
* Level 2: Rogaratinib 600 mg PO BID + fulvestrant 500 mg IM every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 6 patients).

Treatment will continue until disease progression.

Combination, Rogaratinib + palbociclib + fulvestrant

Miguel Ángel Quintela-Fandino

Luis Manso, MD

Ramón Colomer i Bosch

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.

Open label, prospective, multicenter, single-arm, phase I dose-escalation study.

In this case gender is important because it is a specific cancer in women.

Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.

Rogaratinib, Palbociclib and Fulvestrant in Advanced Hormone Receptor Positive, FGFR1/2/3-positive Breast Cancer: Phase I Clinical Trial Plus an Expansion Cohort

Highest dose at which \<1 out of 6 patients experience a DLT.

Percentage of patients with each adverse event.

Time from the date of first dose of study treatment to the date of progression or death (from any cause).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.	NCT04483505	Breast Cancer M... Hormone Recepto...	Combination, Ro...	18 Years -	Fundacion CRIS de Investigación para Vencer el Cáncer
Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.	NCT04483505	Breast Cancer M... Hormone Recepto...	Combination, Ro...	18 Years -	Fundacion CRIS de Investigación para Vencer el Cáncer

Spots Global Cancer Trial Database for combination, rogaratinib + palbociclib + fulvestrant