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

NCT06587789 | Recruiting

• 1 other identifier: 2024-0726
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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: Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer? Participants 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 for three years. During the follow-up, their relevant clinical data will be recorded.

Conditions

Breast Cancer

Keywords

Ribociclib; Breast Cancer; Adjuvant Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-Free Survival(iDFS)

  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, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).

  3 years

Secondary Outcomes (6)

• Distant recurrence-free survival(DRFS)

  3 years

• Distant disease-free survival(DDFS)

  3 years

• Overall Survival

  3 years

• Frequency of AE/SAE

  3 years

• 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

Study Arms (1)

Ribociclib combined with endocrine therapy group

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.

Drug: Ribociclib

Interventions

Ribociclib DRUG

Participants 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 (according to standard clinical practice, TAM or AI, with or without OFS).

Ribociclib combined with endocrine therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population who meet the above mentioned inclusions will be selected from cooperative hospitals.

You may qualify if:

• 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;
• Age 18-80 years old, female (both pre/post menopausal);
• 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.
• 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.
• 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).
• A maximum of 12 months from surgery to enrollment.
• Patients with an ECOG score of ≤3, allowing the combination of other asymptomatic underlying diseases.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Jinhua Central Hospital: collaborator
• Taizhou Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• The Affiliated People's Hospital of Ningbo University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Affiliated Zhoushan Hospital of Wenzhou Medical University: collaborator
• Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chao Ni

CONTACT

13989463951; nicaho428@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-07

Locations

CN (1)