Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587789
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HRHER2- Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Prospective and Observational Study of Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HRHER2- Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HRHER2- breast cancer The main question it aims to answer is
Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HRHER2- breast cancer Participants will receive ribociclib at a dose of 400mg per day for 3 weeks followed by 1 week off 4 weeks for 1 cycle plus physician-selected endocrine therapy for three years During the follow-up their relevant clinical data will be recorded
Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HRHER2- breast cancer Participants will receive ribociclib at a dose of 400mg per day for 3 weeks followed by 1 week off 4 weeks for 1 cycle plus physician-selected endocrine therapy for three years During the follow-up their relevant clinical data will be recorded
Detailed Description:
In this multi-center prospective and observational study we aim to learn about the efficacy and safety of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HRHER2- breast cancer After being evaluated by the researchers as early high-risk HRHER2- breast cancer patients signing the informed consent and being screened to meet the inclusion criteria eligible participants will be enrolled to receive ribociclib at a dose of 400mg per day for 3 weeks followed by 1 week off 4 weeks for 1 cycle plus physician-selected endocrine therapy During there years of follow-up their relevant clinical data will be recorded
Enrolled patients are recommended to receive 3 years of ribociclib combined with ET or until evidence of disease recurrence is observed or other discontinuation criteria are met whichever occurs earliest
ET will be administered during the observational phase of the study 3 years according to the prescription selected by the physician At the end of the research observation phase according to medical indication standard adjuvant ET should continue for 2-8 years and the total treatment duration can be up to 10 years
According to physicians choice participants use the approved standard adjuvant ET eg according to standard clinical practice TAM or AI with or without OFS Fulvestrant should not be used for adjuvant therapy at any time during the study period
Review of imaging ultrasoundCT or MRI of common recurrent sites throughout the body every 3 months before and after dosing and every 6 months after 2 years until disease recurrence or death or the end of this study This is the current follow-up interval recommended by the Chinese Anticancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications Version 2024 which does not increase the burden of follow-up for patients
Records of blood-related indicators according to the instructions of ribociclib blood routine biochemical indicators were reviewed during the treatment follow-up Medical staff graduate students and technicians complete the record of the patient-reported outcomes PROs pre-drug and 13612182436 months post-drug in real time through mutiple questionnaire survey such as WeChat applets phone calls text messaging and face-to-face visits
The study will collect primary and recurrent metastatic tumor tissues and blood using multi-gene detection proteomic and other means to detect samples and explore the biomarkers associated with ribociclib treatment
This study is expected to have an enrollment time of 24 months and a follow-up time of 36 months
Enrolled patients are recommended to receive 3 years of ribociclib combined with ET or until evidence of disease recurrence is observed or other discontinuation criteria are met whichever occurs earliest
ET will be administered during the observational phase of the study 3 years according to the prescription selected by the physician At the end of the research observation phase according to medical indication standard adjuvant ET should continue for 2-8 years and the total treatment duration can be up to 10 years
According to physicians choice participants use the approved standard adjuvant ET eg according to standard clinical practice TAM or AI with or without OFS Fulvestrant should not be used for adjuvant therapy at any time during the study period
Review of imaging ultrasoundCT or MRI of common recurrent sites throughout the body every 3 months before and after dosing and every 6 months after 2 years until disease recurrence or death or the end of this study This is the current follow-up interval recommended by the Chinese Anticancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications Version 2024 which does not increase the burden of follow-up for patients
Records of blood-related indicators according to the instructions of ribociclib blood routine biochemical indicators were reviewed during the treatment follow-up Medical staff graduate students and technicians complete the record of the patient-reported outcomes PROs pre-drug and 13612182436 months post-drug in real time through mutiple questionnaire survey such as WeChat applets phone calls text messaging and face-to-face visits
The study will collect primary and recurrent metastatic tumor tissues and blood using multi-gene detection proteomic and other means to detect samples and explore the biomarkers associated with ribociclib treatment
This study is expected to have an enrollment time of 24 months and a follow-up time of 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None