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)

NCT06656624 | Recruiting Phase 2 DMC

• 1 other identifier: Rachel
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Breast Cancer

Keywords

Ribociclib; ER medium to low expression; HER2 positive

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (7)

• Progression Free Survival2

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Time to treatment failure

  From randomization to treatment failure or withdrawal from the trial; reasons for withdrawal can be patient request, disease progression, death, or adverse events, whichever came first, assessed up to 100 months

• Overall response rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Overall survival(OS)

  From date of randomization until the date of death from any cause, assessed up to 100 months

• Time To Response

  From the date of randomization to the first documented response of either CR or PR, whichever came first, assessed up to 100 months

Study Arms (2)

physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS

ACTIVE COMPARATOR

Drug: physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS

Ribociclib combined with AI±OFS

EXPERIMENTAL

Drug: Ribociclib combined with AI±OFS

Interventions

Ribociclib combined with AI±OFS DRUG

Ribociclib: 600mg /d, 3 weeks continuous oral withdrawal for 1 week; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.

Ribociclib combined with AI±OFS

physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS DRUG

Docetaxel: 100mg/m2 IV drip every 21 days; Paclitaxel: 175mg/m2 every 21 days, IV drip; Paclitaxel for Injection (Albumin Bound): 100\~150mg/m2 IV drip every 7 days; 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; AI: Anastrozole 1mg, 1 time /d, oral; Letrozole: 2.5mg, 1 time /d, oral; Exemestane Tablets: 25mg, 1 time /d, oral Goserelin: 3.6 mg every 28 days, subcutaneous injection in the abdomen.

physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Patient is an adult female ≥ 18 years old at the time of informed consent.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 local laboratory. ER should express in the range of 10% to 50%. ER positive by local laboratory testing.
• 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.
• 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;

You may not qualify 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 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Yidu Central Hospital of Weifang: collaborator
• Affiliated Hospital of Jiangnan University: collaborator
• The Affiliated Jiangyin Hospital of Southeast University Medical College: collaborator

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

Central Study Contacts

Yongmei Yin, Ph.D

CONTACT

025-68307102; ymyin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: August 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)