Actively Recruiting
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-10-24
190
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
Y
Yidu Central Hospital of Weifang
Collaborating Sponsor
AI-Summary
What this Trial Is About
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative advanced breast cancer.
CONDITIONS
Official Title
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients aged 18 years or older at the time of informed consent
- ECOG performance status of 0 to 2
- Histologically confirmed recurrent or metastatic breast cancer, including stage IV or locally advanced inoperable cases
- Estrogen receptor expression between 10% and 50% and/or progesterone receptor positive breast cancer confirmed by local laboratory
- HER2-negative breast cancer defined by negative in situ hybridization or IHC status of 0, 1+, or 2+ with negative in situ hybridization if IHC is 2+
- Rapid disease progression determined by physician, including symptomatic visceral metastases, rapid disease worsening, or markedly symptomatic non-visceral disease needing chemotherapy
- No prior systemic anti-cancer therapy at recurrence/metastasis stage
- At least one measurable lesion according to RECIST 1.1 criteria
- Postmenopausal or pre/perimenopausal female patients willing to receive LHRHa during the study
- Laboratory values meeting specified hematology, renal, and liver function criteria prior to enrollment
You will not qualify if you...
- Previous systemic anti-cancer therapy at recurrence/metastasis stage
- Prior treatment with CDK4/6 inhibitors during neoadjuvant or adjuvant phases
- Symptomatic central nervous system metastases
- History of clinically symptomatic cardiovascular, hepatic, respiratory, renal, hematologic-endocrine, or neuropsychiatric disorders
- Serious concurrent diseases such as infections or conditions affecting oral drug administration and absorption
- Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test within 14 days before first dose
- Poor general condition unable to tolerate chemotherapy
- Any condition the investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
Y
Yongmei Yin, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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