OncoMatch/Clinical Trials/NCT05978648
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Is NCT05978648 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast neoplasms.
Treatment: Trilaciclib · Epirubicin · Cyclophosphamide · Paclitaxel · Docetaxel · Carboplatin · Trastuzumab · Pertuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (< 1% nuclear staining by IHC) (< 1% nuclear staining)
ER, PR negative (< 1% nuclear staining as assessed by immunohistochemistry [IHC])
Required: PR (PGR) negative (< 1% nuclear staining by IHC) (< 1% nuclear staining)
ER, PR negative (< 1% nuclear staining as assessed by immunohistochemistry [IHC])
Required: HER2 (ERBB2) negative (HER2/CEP17 ratio < 2.0 or mean HER2 gene copy number < 4 signals/nucleus detected by IHC 0 or 1+ or ISH) (HER2/CEP17 ratio < 2.0 or mean HER2 gene copy number < 4 signals/nucleus detected by IHC 0 or 1+ or ISH)
HER2 negative (HER2/CEP17 ratio < 2.0 or mean HER2 gene copy number < 4 signals/nucleus detected by IHC 0 or 1+ or in situ hybridization [ISH])
Required: HER2 (ERBB2) positive (HER2/CEP17 ratio ≥ 2.0 or HER2 gene copy number ≥ 4 signals/nucleus detected by IHC 3+ and ISH; HER2 gene copy number ≥ 6 signals/nucleus detected by IHC 3+ or 2+ and ISH) (HER2/CEP17 ratio ≥ 2.0 or HER2 gene copy number ≥ 4 signals/nucleus detected by IHC 3+ and ISH; HER2 gene copy number ≥ 6 signals/nucleus detected by IHC 3+ or 2+ and ISH)
HER2 positive: HER2/CEP17 ratio ≥ 2.0 or HER2 gene copy number ≥ 4 signals/nucleus detected by IHC 3+ and ISH; HER2 gene copy number ≥ 6 signals/nucleus detected by IHC 3+ or 2+ and ISH
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: neoadjuvant therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy)
Prior neoadjuvant therapy (including chemotherapy, targeted therapy, immunotherapy, or radiotherapy)
Lab requirements
Blood counts
hb ≥ 100 g/l (no esa and blood transfusion within 14 days before the first dose); anc ≥ 2 × 10^9/l (no g-csf within 14 days before the first dose); platelet count ≥ 100 × 10^9/l (no rhtpo/rhil-11 and platelet transfusion within 14 days before the first dose)
Kidney function
serum creatinine ≤ 1.5 × uln, endogenous creatinine clearance > 50 ml/min (cockcroft-gault formula)
Liver function
alt ≤ 2.5 × uln, ast ≤ 2.5 × uln, total bilirubin ≤ 1.5 × uln
Cardiac function
left ventricular ejection fraction (lvef) ≥ 55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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