OncoMatch/Clinical Trials/NCT05978648
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Is NCT05978648 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
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.
Frequently asked questions
Is NCT05978648 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 negative (< 1% nuclear staining by IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (< 1% nuclear staining by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (HER2/CEP17 ratio < 2.0 or mean HER2 gene copy number < 4 signals/nucleus detected by IHC 0 or 1+ or ISH) is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages