MedTrace Logo

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

NCT05978648 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-11-30

No results posted yet for this study

Summary

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

  • Breast Neoplasms

Interventions

DRUG

Trilaciclib

240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

DRUG

Epirubicin

90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

DRUG

Cyclophosphamide

600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

DRUG

Paclitaxel

80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.

DRUG

Docetaxel

75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.

DRUG

Carboplatin

area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.

DRUG

Trastuzumab

8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

DRUG

Pertuzumab

840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Sponsors & Collaborators

  • wang shusen

    lead OTHER

Principal Investigators

  • Shusen Wang, MD · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978648 on ClinicalTrials.gov