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Trial Title:
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
NCT ID:
NCT06375707
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR positive /HER2 negative
Ribociclib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS
Description:
Docetaxel: 100mg/m2 IV every 21 days Paclitaxel: 175mg/m2 every 21 days, IV drip
Vinorelbine: 25mg/ m2 on days 1 and 8 of each cycle, 1 cycle in 21 days, IV drip
Capecitabine: 1000mg/m2, 2 times/d, 2 consecutive weeks of oral discontinuation for 1
week.
Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole
1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral
Arm group label:
physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS
Intervention type:
Drug
Intervention name:
Ribociclib combined with NSAI±OFS
Description:
Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week NSAI: Anastrozole
1mg, 1 time /d, oral or Letrozole: 2.5mg, 1 time /d, oral
Arm group label:
Ribociclib combined with NSAI±OFS
Summary:
Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus
physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced
breast cancer.
Detailed description:
The main goal of this clinical trial is to compare in the efficacy of Ribociclib in
combination with NSAI versus physician's choice of chemotherapy sequential endocrine
therapy in HR+/HER2- advanced breast cancer and evaluate the PCR DFS,OS and safety of the
subjects. The main question it aims is comparing the efficacy and safety of first-line
application of CDK4/6 inhibitors combined with initial endocrine therapy versus
sequential endocrine therapy after chemotherapy induction therapy in HR+/HER2-advanced
breast cancer with rapidly progressive disease.
This study is planned to include 144 patients with HR+/HER2-advanced breast cancer with
rapidly progressive disease between November 2023 and November 2025 who meet the entry
criteria. A central dynamic randomisation system was used for 1:1 allocation to the
repositories combined with NSAI treatment group and the physician's choice of
chemotherapy sequential repositories combined with NSAI treatment group, with
stratification factors including: level of HR expression, and presence of liver/lung
metastases.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient is an adult female ≥ 18 years old at the time of informed consent.
2. ECGO rating 0-2.
3. Histologically confirmed recurrent or metastatic breast cancer, including patients
initially diagnosed as stage IV or locally advanced inoperable patients.
4. Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer based
on the most recently analyzed tissue sample and all tested by local laboratory. ER
should be more than 10% ER positive by local laboratory testing.
5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization
test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ
hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and
based on the most recently analyzed tissue sample.
6. Determination by the physician that the patient is in a rapid disease progression
situation:
- Symptomatic visceral metastases
- Rapid progression of disease or impending visceral compromise.
- Markedly symptomatic non visceral disease if the treating physician opt to give
chemotherapy for rapid palliation of patients symptoms.
7. Patient hasn't received systemic anti-cancer therapy at the stage of
recurrence/metastasis.
8. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria)
9. Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre
or perimenopausal female patients must be willing to receive LHRHa during the study
period.
10. All patients were required to meet the following laboratory biochemical values prior
to enrolment:
- Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L;
- Renal function: serum creatinine ≤ upper limit of normal value;
- Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times
the upper limit of normal values, and ≤1.25 x the upper limit of normal values
for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times
the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of
normal value.
Exclusion Criteria:
1. Patient has received systemic anti-cancer therapy at the stage of
recurrence/metastasis.
2. Those who have been treated with CDK4/6 inhibitors in the neoadjuvant/adjuvant
phase.
3. Patients those with symptomatic CNS metastases.
4. Patient has a history of clinically symptomatic cardiovascular, hepatic,
respiratory, renal and haemato-endocrine system or neuropsychiatric disorders.
5. Patient has a serious concomitant disease, such as an infectious disease; has
multiple factors that affect the oral administration and absorption of the drug.
6. Pregnant or lactating women (women of childbearing age must have had a negative
pregnancy test within 14 days prior to the first dose; if positive, pregnancy must
be ruled out by ultrasound).
7. Patients in poor general condition who cannot tolerate chemotherapy treatment.
8. The investigator considers the patient unsuitable for entry into this study.
Gender:
Female
Gender based:
Yes
Gender description:
Patient is an adult female ≥ 18 years old at the time of informed consent.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Li, Ph.D
Phone:
025-68306360
Email:
real.lw@163.com
Investigator:
Last name:
Wei Li, Ph.D
Email:
Principal Investigator
Start date:
January 9, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375707
