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Compares treatment options for Advanced Breast Cancer
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)
ClinicalTrials.gov ID: NCT06656624
What this study is testing
What is Ribociclib combined with AI±OFS?
Ribociclib combined with AI±OFS is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Patient is an adult female ≥ 18 years old at the time of informed consent.
- ECGO rating 0-2.
- Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable...
- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast...
- 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...
You likely can't join if
- Patient has received systemic anti-cancer therapy at the stage of recurrence/metastasis.
- Those who have been treated with CDK4/6 inhibitors in the neoadjuvant/adjuvant phase.
- Patients those with symptomatic CNS metastases.
- Patient has a history of clinically symptomatic cardiovascular, hepatic, respiratory, renal and haemato-endocrine system or neuropsychiatric...
- Patient has a serious concomitant disease, such as an infectious disease; has multiple factors that affect the oral administration and absorption of...
- 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...
See the full eligibility criteria
- Patient is an adult female ≥ 18 years old at the time of informed consent.
- ECGO rating 0-2.
- Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable patients.
- 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...
- 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...
- 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.
- Patient hasn't received systemic anti-cancer therapy at the stage of recurrence/metastasis.
- Patient must have at least one measurable lesion (according to RECIST 1.1 criteria)
- 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.
- 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...
- Patient has received systemic anti-cancer therapy at the stage of recurrence/metastasis.
- Those who have been treated with CDK4/6 inhibitors in the neoadjuvant/adjuvant phase.
- Patients those with symptomatic CNS metastases.
- Patient has a history of clinically symptomatic cardiovascular, hepatic, respiratory, renal and haemato-endocrine system or neuropsychiatric disorders.
- Patient has a serious concomitant disease, such as an infectious disease; has multiple factors that affect the oral administration and absorption of the drug.
- 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).
- Patients in poor general condition who cannot tolerate chemotherapy treatment.
- The investigator considers the patient unsuitable for entry into this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.