Actively Recruiting
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Led by wang shusen · Updated on 2023-11-30
116
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this multicenter, two-cohort, exploratory clinical trial is to evaluate patients with early stage hormone receptor-negative breast cancer receiving standard adjuvant chemotherapy after surgery. The main question it aims to answer is: • The efficacy and safety of trilaciclib administered before standard adjuvant chemotherapy regimen using the incidence of grade 3/4 neutropenia as the primary efficacy endpoint. Participants will divide into two treatment cohorts according to molecular typing type: * Cohort A will be planned to include post-operative triple-negative breast cancer(TNBC) patients with lymph node positive or tumor \> 2 cm treated with trilaciclib combined with epirubicin and cyclophosphamide followed by weekly paclitaxel; * Cohort B will be planned to include HER2-positive/HR-negative breast cancer patients with axillary node positive or tumor \> 2 cm treated with trilaciclib combined with docetaxel, carboplatin and trastuzumab with or without pertuzumab.
CONDITIONS
Official Title
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed and adequately resected non-metastatic primary invasive breast cancer
- Cohort A: ER and PR negative (less than 1% nuclear staining), HER2 negative; Cohort B: ER and PR negative, HER2 positive
- Positive lymph nodes or tumor larger than 2 cm
- Interval between surgery and first dose 60 days or less
- ECOG performance status 0-1
- Adequate bone marrow function without recent growth factors or transfusions
- Adequate liver, kidney, and cardiac function (ALT, AST, bilirubin, creatinine, creatinine clearance, LVEF requirements)
- Recovery from prior surgery toxicities to Grade 1 or baseline (except hair loss)
- Females of childbearing potential must agree to reliable contraception and have a negative pregnancy test within 7 days prior to dosing
- Voluntary informed consent and willingness to comply with study and follow-up
You will not qualify if you...
- Prior neoadjuvant therapy including chemotherapy, targeted therapy, immunotherapy, or radiotherapy
- History of other malignancies within 5 years except basal cell carcinoma or cervical carcinoma in situ
- Any T4, N2, known N3, or metastatic (M1) breast cancer
- Inability to receive or tolerate postoperative chemotherapy
- Heart conditions making epirubicin, docetaxel, trastuzumab, or pertuzumab unsafe, including myocardial infarction, heart failure, angina requiring medication, severe arrhythmia, significant valvular disease, or poorly controlled hypertension
- Known allergy to study drug components
- Any other condition making participation inappropriate as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun-yat sen university cancer center
Guangzhou, Gangdong, China, 510060
Actively Recruiting
Research Team
S
Shusen Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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