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The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

ConditionBreast Neoplasm
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as a neoadjuvant treatment for triple negative breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly treated patients aged ≥ 18 years;

ECOG score 0-1;

Histologically confirmed invasive breast cancer

Tumor staging: cT2-4, cNany, cM0 or cT1, cN1-3, cM0;

Disqualifiers

Previously received anti-tumor treatment for any malignant tumor;

Subjects who are unable to accept or tolerate preoperative chemotherapy due to various reasons;

The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures;

A confirmed history of heart failure or systolic dysfunction (LVEF<50%);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trilaciclib plus chemotherapy

    Drug

    Trilaciclib: 240mg/m2 IV d1,within 4h before chemotherapy epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles

  • Chemotherapy

    Drug

    epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Trilaciclib plus chemotherapy (Trilaciclib+AC-T)Experimental treatment 1 intervention
Group B: Chemotherapy (AC-T)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of CIN

The incidence of ≥3 grade neutropenia

Time frame
From date of randomization until the date of surgery, assessed up to 6 months

Secondary outcomes

1

The incidence of CIT

The incidence of ≥3 grade thrombopenia

Time frame
From date of randomization until the date of surgery, assessed up to 6 months
2

The incidence of CIA

The incidence of ≥3 grade anemia

Time frame
From date of randomization until the date of surgery, assessed up to 6 months
3

pCR rate

Rate of pCR using the definition of ypT0/Tis ypN0 as assessed by the local pathologist.

Time frame
From date of randomization until the date of surgery, assessed up to 6 months.
4

ORR

Objective Response Rate

Time frame
From date of randomization until the date of PD (up to 24 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: