Comparing Ribociclib with Chemotherapy for Advanced Breast Cancer

Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Medium to Low Expression/HER2-negative Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Study

This study is testing whether a new drug called Ribociclib, combined with another medication, can work better than standard chemotherapy for women with advanced breast cancer that has certain characteristics.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06656624 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Ribociclib combined with an aromatase inhibitor compared to the physician's choice of sequential chemotherapy in treating advanced breast cancer with medium to low estrogen receptor expression and HER2-negative status. The study will enroll 190 adult female patients who meet specific eligibility criteria, including histologically confirmed breast cancer and rapid disease progression. Participants will be randomized into treatment groups using a stratified grouping and block randomization method to ensure balanced representation based on disease characteristics.

Who should consider this trial

Good fit: Ideal candidates for this study are adult females aged 18 and older with ER medium to low expression and HER2-negative advanced breast cancer.

Not a fit: Patients with HER2-positive breast cancer or those with low estrogen receptor expression below the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective first-line treatment option for patients with advanced breast cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with CDK4/6 inhibitors in similar patient populations, suggesting potential for success in this approach.

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 express in the range of 10% to 50%. 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.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Yongmei Yin, Ph.D

Conditions: Advanced Breast Cancer, Ribociclib, ER medium to low expression, HER2 positive