Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.
NCT04483505
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
1. Women ≥18 years-old.
2. Diagnostic of metastatic or locally advanced non-resectable breast cancer.
3. Ability to understand and signing of the PIS/ICF for FGFR testing. FGFR testing will be performed centrally at CNIO (RNAscope and FISH).
4. Ability to understand and signing the written PIS/ICF for study treatment eligibility.
5. Availability of fresh tumor biopsy specimen for FGFR1/3 mRNA expression and FISH testing.
6. Hormone-receptor positivity defined by at least 5% positivity of ER and/or PR (no central laboratory testing is required).
7. Positivity of FGFR1/2/3 by RNA-scope and/or FISH.
8. 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).
9. Recovery of toxicities from previous regimens to equal or below tolerable grade II.
10. HER2-negativity (Herceptest 0+, 1+ or 2+ with negative FISH/CISH/SISH).
11. ECOG performance status of 0/1.
12. Life expectancy of >24 weeks.
13. Adequate bone marrow, liver and renal function as assessed by laboratory requirements:
1. Absolute neutrophil count (ANC) ≥ 1,500/mm3
2. Hemoglobin ≥ 10 g/dL (without transfusion or erythropoietin .
3. Platelet count ≥ 100,000/mm3
4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
6. Alkaline phosphatase ≤ 2.5 times ULN
7. Lipase and amylase ≤ 2 × ULN.
8. Serum albumin ≥ 2.5 g/dl.
9. Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2
14. INR ≤ 1.5 × ULN and PTT or activated PTT (aPTT) ≤ 1.5 × ULN.
15. Negative serum pregnancy test in women of childbearing potential.
16. Women of reproductive potential must agree to use highly effective contraception when sexually active.
17. Evaluable disease according to RECIST 1.1 criteria.
1. Involvement in the planning and/or conduct the study.
2. Previous enrollment in the present study.
3. Previous or concurrent cancer except:
1. Cervical carcinoma in situ.
2. Treated basal-cell carcinoma or squamous cell skin cancer.
3. Any other cancer curatively treated > 3 years before the first study drug
administration.
4. Receipt the last dose of anticancer therapy at least 21 days prior to the first dose
of study drug.
5. Acute toxic effects of previous anticancer chemotherapy or immunotherapy have to be
normalized completely
6. Anti-cancer therapy is defined as any agent or combination of agents with clinically
proven anti-tumor activity
7. Previous treatment with anti-FGFR directed therapies.
8. Irradiation of single bony lesions with risk of fracture. Zoledronic acid or denosumab
started prior to trial registration is allowed.
9. Symptomatic metastatic brain or meningeal tumors.
10. History or current condition of an uncontrolled cardiovascular disease including any
of the following conditions:
1. Congestive heart failure, unstable angina (symptoms of angina at rest) or
2. New-onset angina
3. Myocardial infarction (MI).
4. Unstable cardiac arrhythmias requiring anti-arrhythmic therapy.
5. Patients with known coronary artery disease, congestive heart failure not meeting
the above criteria, must be on a stable medical regimen.
11. Known human immunodeficiency virus (HIV) infection.
12. Active hepatitis B virus or hepatitis C infection requiring treatment.
1. Patients with past HBV infection or resolved HBV infection are eligible if HBV
DNA is negative.
2. Patients positive for hepatitis C virus are eligible only if polymerase chain
reaction is negative for HCV RNA.
13. 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.
14. Previous or concomitant participation in another clinical study with investigational
medicinal products.
15. Active tuberculosis.
16. Clinically active infections.
17. Treatment with therapeutic oral or i.v. antibiotics.
18. Patients receiving prophylactic antibiotics are eligible.
19. Seizure disorder requiring medication.
20. History of organ allograft.
21. Evidence or history of bleeding diathesis or coagulopathy.
22. Any hemorrhage / bleeding event CTCAE v.5.0 ≥ Grade 3.
23. Serious, non-healing wound, ulcer or bone fracture.
24. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in
the formulation.
25. Any malabsorption condition.
26. Current diagnosis of any retinal disorders including retinal detachment, retinal
pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion.
27. Peripheral sensory neuropathy of CTCAE v.5.0 Grade 2 or higher.
28. Current evidence of endocrine alteration of calcium phosphate homeostasis.
29. Concomitant therapies that are known to increase serum phosphate levels.
30. Any condition that is unstable or could jeopardize the safety of the patient and their
compliance in the study.
31. Breast-feeding.
32. Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4.
33. Autologous bone marrow transplant or stem cell rescue.
34. Major surgery, open biopsy or significant traumatic injury.
35. Renal failure requiring peritoneal dialysis or hemodialysis.
36. Systolic/diastolic blood pressure ≤ 100/60 mmHg and concurrent heart rate ≥ 100/min.
37. Inability to swallow oral tablets.
38. Close affiliation with the investigational site; e.g. a close relative of the
investigator or a dependent person.
39. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results.
40. Arterial or venous thrombotic events or embolic events such as cerebrovascular
accident, deep vein thrombosis or pulmonary embolism.
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| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. | |||||||||
| Official Title ICMJE | Rogaratinib, Palbociclib and Fulvestrant in Advanced Hormone Receptor Positive, FGFR1/2/3-positive Breast Cancer: Phase I Clinical Trial Plus an Expansion Cohort | |||||||||
| Brief 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Open label, prospective, multicenter, single-arm, phase I dose-escalation study. Masking: None (Open Label)Primary Purpose: Other | |||||||||
| Condition ICMJE |
| |||||||||
| Intervention ICMJE | Drug: Combination, Rogaratinib + palbociclib + fulvestrant
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:
Treatment will continue until disease progression. | |||||||||
| Study Arms ICMJE | Experimental: Rogaratinib + palbociclib + fulvestrant
Intervention: Drug: Combination, Rogaratinib + palbociclib + fulvestrant | |||||||||
| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE | 19 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | February 3, 2023 | |||||||||
| Estimated Primary Completion Date | February 3, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04483505 | |||||||||
| Other Study ID Numbers ICMJE | ROGABREAST 2020-000055-12 ( EudraCT Number ) | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
| |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Fundacion CRIS de Investigación para Vencer el Cáncer | |||||||||
| Study Sponsor ICMJE | Fundacion CRIS de Investigación para Vencer el Cáncer | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Fundacion CRIS de Investigación para Vencer el Cáncer | |||||||||
| Verification Date | December 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||