Phase I/II study to determine the safety and efficacy of Ribociclib in combination with hormone therapy and hypofractionated radiotherapy in breast cancer, with positive hormone receptors and negative HER2 status, in newly diagnosed, not immediately operable (or wishing to avoid surgery), elderly patient

Phase 1

• Conditions: breast cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501527-24-00
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 85

Inclusion Criteria

1.Patient registered in the study-screening phase;, 10.Must be able to swallow ribociclib;, 11.Subjects must be able to communicate with the investigator and comply with the requirements of the study procedures, 12.Must be willing to remain at the clinical site as required by the protocol., 2.Patient receiving, during the screening phase, 3 cycles of Ribociclib at 600mg without dose decreased;, 3.Have a performance status of 0 to 2 on the ECOG Performance Scale;, 4.Not immediately operable (stage of disease, comorbidities or refusal of surgery) with tumor in place;, 5.Measurable disease based on RECIST 1.1;, 6.Demonstrate adequate organ functions: Hemoglobin > 9 g/dL; Absolute neutrophil count > 1.5 G/L; Platelets > 100 G/L; etc..., 7. Standard 12-lead ECG values defined as the mean of the triplicate ECGs • QTcF interval at screening < 450 msec (QT interval using Fridericia’s correction) • Mean resting heart rate 50-90 bpm (determined from the ECG)Indication of treatment with hormone therapy and hypofractioned radiotherapy;, 8.Patients having taken cognizance of the information sheet and having signed the informed consent;, 9.Patients covered by medical insurance.

Exclusion Criteria

1.Patient eligible to resection surgery after 3 cycles of Ribociclib;, 2.Patient eligible to neoadjuvant chemotherapy;, 3.Concomitant bilateral breast cancer;, 4.Known additional malignancy. Exceptions include basal cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy;, 5.Contraindication for hormone therapy, Ribobociblib or radiotherapy;, 6.Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.), 7.Severe dementia;, 8.Patients unable to express their consent;, 9.Vulnerable persons as defined by article L1121-5 - 8: a.Pregnant women, women in labor or breast-feeding mothers, persons deprived of their freedom by judicial or administrative decision, persons hospitalized without their consent by virtue of articles L. 3212-1 and L. 3213-1 and who are not subject to the provisions of article L. 1121-8; b.Persons admitted to a social or health facility for reasons other than research; c.Adults subject to a legal protection order or unable to give their consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified