Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Ribociclib

• Registration Number: NCT06587789
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. The main question it aims to answer is:
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Detailed Description

In this multi-center, prospective and observational study, we aim to learn about the efficacy and safety of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. After being evaluated by the researchers as early high-risk HR+HER2- breast cancer patients, signing...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 286

Inclusion Criteria

1. Before any trial-related procedures, sign a written informed consent, and be willing and able to follow the planned visits, research treatment, laboratory examination and other test procedures;

2. Age 18-80 years old, female (both pre/post menopausal);

3. The patient's initial diagnostic tissue specimens were confirmed to be HR+, HER2- early high-risk invasive breast cancer without evidence of disease recurrence or distant metastasis.

4. The patient must have undergone radical surgery for the primary breast tumor. The cut edge of the removed specimen must be free from histological tumor residue (including invasive breast cancer or ductal carcinoma in situ [DCIS]). If supraclavicular or internal breast lymph nodes are considered for metastasis but cannot be surgically removed, radiotherapy should be carried out in the remaining lymph node drainage area in accordance with local guidelines.

5. After surgical resection, the tumor was completely removed, and there was no tumor at the end of the surgical specimen microscope, and it belonged to one of the following stages:

   • Pathological Stage IIB or III
   • Pathological Stage IIA as listed below:
   • N1 or N0, and: grade 3, or grade 2, meeting any of the following criteria:

   ( Ki67 ≥ 20%, or Oncotype DX breast recurrence score ≥ 26, or MammaPrint classification of high risk)

   Attention:

   • For patients with tumor anatomical stage IIA N0: Patients are ineligible if Grade 1 or Unknown (Gx).
   • Patients receiving neoadjuvant therapy must meet the above criteria in any preoperative staging/samples and/or surgical specimens (for staging, if Stage IIA, N0, also including grading and Ki67 or gene expression testing).
   • AJCC 8th edition anatomic staging requirements determine T, N, and M categories. ALND is the preferred method for axillary lymph node staging; however, SLN dissection may be used to determine N classification in the following situations: No metastasis in the SLN (patients are considered as pN0); Slight metastasis in the SLN (patient considered as pN1mi); Patients with T1-2 and no clinically significant nodes before surgery, no neoadjuvant chemotherapy, at least 1 macrometastasis in 1 or 2 SLNs, no clustered swollen lymph nodes or severe extra-lymph node diseases during SLN clearance (patients are considered as pN1).

6. A maximum of 12 months from surgery to enrollment.

7. Patients with an ECOG score of ≤3, allowing the combination of other asymptomatic underlying diseases.

8. The patient can swallow oral endocrine drugs, regardless of the type of endocrine drugs.

9. The patient agrees to take paraffin samples from the primary lesions (including the primary lesions and lymph nodes), tumor tissue and blood samples from the recurrent lesions for future exploratory biomarker analyses

10. The patient has completed (neo)adjuvant chemotherapy and standard radiotherapy (when indicated) in accordance with clinical practice guidelines.

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Exclusion Criteria

1. The patient has received any CDK4/6 inhibitors in the past.
2. Metastatic diseases (including contralateral axillary lymph nodes)
3. Patients have received ET (tamoxifen or aromatase inhibitors or raloxifene) for the prevention of breast cancer.
4. Unwilling to participate in the quality of life questionnaire score or provide tissue samples at the time of recurrence

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ribociclib combined with endocrine therapy group	Ribociclib	Patients with early high-risk HR+HER2- breast cancer will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy as adjuvant therapy. During three years of follow-up, their relevant clinical data will be recorded.

Primary Outcome Measures

Name	Time	Method
Invasive Disease-Free Survival(iDFS)	3 years	iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, o...

Secondary Outcome Measures

Name	Time	Method
Distant recurrence-free survival(DRFS)	3 years	DRFS is defined as the time from date of randomization to date of first event of distant recurrence, or death (any cause).
Distant disease-free survival(DDFS)	3 years	DDFS using STEEP criteria. DDFS is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Overall Survival	3 years	OS is defined as the time from date of randomization to date of death due to any cause.
Frequency of AE/SAE	3 years	Adverse Events assessed by investigator (type, frequency, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0)), seriousness)
Quality of life by the Quality of life questionnaire - Core 30 (QLQ-C30)	At baseline and 1,3,6,12,18,24,36 months after therapy	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.; ...
Quality of life by the Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)	At baseline and 1,3,6,12,18,24,36 months after therapy	This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.; ...

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China