Rogaratinib Palbociclib y Fulvestrant in Patients With Breast Cancer.

  • STATUS
    Recruiting
  • End date
    Feb 3, 2023
  • participants needed
    19
  • sponsor
    Fundacion CRIS de Investigación para Vencer el Cáncer
Updated on 27 January 2021

Summary

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.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Malignant Neoplasm of Breast
Treatment Combination, Rogaratinib + palbociclib + fulvestrant
Clinical Study IdentifierNCT04483505
SponsorFundacion CRIS de Investigación para Vencer el Cáncer
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Breast Cancer Metastatic or Metastatic Breast Cancer or Hormone Receptor Positive Malignant Neoplasm of Breast or Stage IV Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Hormone Receptor Positive Malignant Neoplasm of Breast or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer or Hormone Receptor Positive Malignant Neoplasm of Breast or Breast Cancer Metastatic?
Women 18 years-old
Diagnostic of metastatic or locally advanced non-resectable breast cancer
Ability to understand and signing of the PIS/ICF for FGFR testing. FGFR testing will be performed centrally at CNIO (RNAscope and FISH)
Ability to understand and signing the written PIS/ICF for study treatment eligibility
Availability of fresh tumor biopsy specimen for FGFR1/3 mRNA expression and FISH testing
Hormone-receptor positivity defined by at least 5% positivity of ER and/or PR (no central laboratory testing is required)
Positivity of FGFR1/2/3 by RNA-scope and/or FISH
Patients must have undergone a previous hormonal treatment line for metastatic disease, with anastrozole, letrozole or exemestane, plus a cell cycle inhibitor (palbociclib, ribociclib or abemaciclib)
Recovery of toxicities from previous regimens to equal or below tolerable grade II
HER2-negativity (Herceptest 0+, 1+ or 2+ with negative FISH/CISH/SISH)
ECOG performance status of 0/1
Life expectancy of >24 weeks
Adequate bone marrow, liver and renal function as assessed by laboratory requirements
Absolute neutrophil count (ANC) 1,500/mm3
Hemoglobin 10 g/dL (without transfusion or erythropoietin
Platelet count 100,000/mm3
Total bilirubin 1.5 the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 ULN
Alkaline phosphatase 2.5 times ULN
Lipase and amylase 2 ULN
Serum albumin 2.5 g/dl
Glomerular filtration rate (GFR) 60 mL/min/1.73 m2
INR 1.5 ULN and PTT or activated PTT (aPTT) 1.5 ULN
Negative serum pregnancy test in women of childbearing potential
Women of reproductive potential must agree to use highly effective contraception when sexually active
Evaluable disease according to RECIST 1.1 criteria

Exclusion Criteria

Involvement in the planning and/or conduct the study
Previous enrollment in the present study
Previous or concurrent cancer except
Cervical carcinoma in situ
Treated basal-cell carcinoma or squamous cell skin cancer
Any other cancer curatively treated > 3 years before the first study drug administration
Receipt the last dose of anticancer therapy at least 21 days prior to the first dose of study drug
Acute toxic effects of previous anticancer chemotherapy or immunotherapy have to be normalized completely
Anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity
Previous treatment with anti-FGFR directed therapies
Irradiation of single bony lesions with risk of fracture. Zoledronic acid or denosumab started prior to trial registration is allowed
Symptomatic metastatic brain or meningeal tumors
History or current condition of an uncontrolled cardiovascular disease including any of the following conditions
Congestive heart failure, unstable angina (symptoms of angina at rest) or
New-onset angina
Myocardial infarction (MI)
Unstable cardiac arrhythmias requiring anti-arrhythmic therapy
Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, must be on a stable medical regimen
Known human immunodeficiency virus (HIV) infection
Active hepatitis B virus or hepatitis C infection requiring treatment
Patients with past HBV infection or resolved HBV infection are eligible if HBV DNA is negative
Patients positive for hepatitis C virus are eligible only if polymerase chain reaction is negative for HCV RNA
Any condition that in the opinion of the investigator would interfere with evaluation of study treatment or interpretation of patient safety or study results, or inability to comply with the study and follow-up procedures
Previous or concomitant participation in another clinical study with investigational medicinal products
Active tuberculosis
Clinically active infections
Treatment with therapeutic oral or i.v. antibiotics
Patients receiving prophylactic antibiotics are eligible
Seizure disorder requiring medication
History of organ allograft
Evidence or history of bleeding diathesis or coagulopathy
Any hemorrhage / bleeding event CTCAE v.5.0 Grade 3
Serious, non-healing wound, ulcer or bone fracture
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
Any malabsorption condition
Current diagnosis of any retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
Peripheral sensory neuropathy of CTCAE v.5.0 Grade 2 or higher
Current evidence of endocrine alteration of calcium phosphate homeostasis
Concomitant therapies that are known to increase serum phosphate levels
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Breast-feeding
Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4
Autologous bone marrow transplant or stem cell rescue
Major surgery, open biopsy or significant traumatic injury
Renal failure requiring peritoneal dialysis or hemodialysis
Systolic/diastolic blood pressure 100/60 mmHg and concurrent heart rate 100/min
Inability to swallow oral tablets
Close affiliation with the investigational site; e.g. a close relative of the investigator or a dependent person
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Arterial or venous thrombotic events or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism
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