NCT05978648: SMA-BC-002

Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting now Phase 2 Last updated 30 November 2023

What this trial tests

Phase 2 trial testing Trilaciclib in Breast Neoplasms in 116 participants. Currently enrolling.

Timeline

20 September 2023

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	wang shusen
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	20 September 2023
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

• Trilaciclib — full drug profile →
• Epirubicin (EPIRUBICIN) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Paclitaxel — full drug profile →
• Docetaxel
• Carboplatin
• Trastuzumab
• Pertuzumab

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

wang shusen — full company profile →

Who can join

18 and older, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.
   Postigo-Corrales F, Beltrán-Videla A, Lázaro-Sánchez AD, Hurtado AM, et al · · 2025 · cited 5× · PMID 40806254 · DOI 10.3390/ijms26157119
2. Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
   Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7
3. Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
   Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560
4. Alternate actions of CDK4/6 inhibitors beyond cell cycle blockade: unexplored roles in therapy resistance.
   Scordamaglia D, Talia M, Zicarelli A, Mondino AA, et al · · 2025 · PMID 41388212 · DOI 10.1007/s10555-025-10307-w