Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

NCT06341621 | Recruiting Phase 3 DMC

• 1 other identifier: SCHBCC-N071
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib

Conditions

Breast Cancer

Keywords

adjuvant chemotherapy omission; adjuvant abemeciclib

Outcome Measures

Primary Outcomes (1)

• Invasive disease free survival

  5 year

Secondary Outcomes (4)

• disease free survival

  5 year

• distant disease free survival

  5 year

• overall survival

  5 year

• Time Frame: 5 years] 5. adverse effects adverse effects

  5 year

Study Arms (2)

endocrine drug plus 3-year abemaciclib without chemo

EXPERIMENTAL

aromatase inhibitors with or without GnRHa plus 3-year lower dose (100mg bid) abemaciclib without chemotherapy.

Drug: 3-year abemaciclib without chemo

treatment of physician's choice

ACTIVE COMPARATOR

treatment of physician's choice, including whether to receive chemotherapy, the chemotherapy regimen and the endocrine therapy regimen.

Drug: treatment of physician's choice

Interventions

3-year abemaciclib without chemo DRUG

aromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy.

endocrine drug plus 3-year abemaciclib without chemo

treatment of physician's choice DRUG

treatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen.

treatment of physician's choice

Eligibility Criteria

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

You may qualify if:

• women aged 18-80 years old;
• Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2，and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) .
• ER≥50%
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤
• ×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula).
• Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

You may not qualify if:

• Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#;
• Has bilateral breast cancer;
• Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
• Has metastatic (Stage 4) breast cancer;
• Has any ≥T3 lesion
• Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
• Patients participating in other clinical trials at the same time;
• Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
• Has severe or uncontrolled infection;
• the researchers judged patients to be unsuitable for the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhimin Cancer Shao

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhimin Shao, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.com

Yin Liu, MD

CONTACT

+8664175590; liuyinfudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 2, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (1)