Trial Title:
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
NCT ID:
NCT05978648
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Docetaxel
Cyclophosphamide
Carboplatin
Trastuzumab
Epirubicin
Pertuzumab
Conditions: Keywords:
Trilaciclib; HR-Negative Breast Cancer; Adjuvant Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib
Description:
240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration
on the same day
Arm group label:
Cohort A: Triple-negative Breast Cancer
Arm group label:
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer
Other name:
COSELA®
Other name:
G1T28
Intervention type:
Drug
Intervention name:
Epirubicin
Description:
90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
Arm group label:
Cohort A: Triple-negative Breast Cancer
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
Arm group label:
Cohort A: Triple-negative Breast Cancer
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.
Arm group label:
Cohort A: Triple-negative Breast Cancer
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.
Arm group label:
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.
Arm group label:
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
Arm group label:
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
Arm group label:
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age ≥ 18 years;
- breast cancer meets the following criteria:
- Histologically or cytologically confirmed and adequately resected
non-metastatic primary invasive breast cancer;
- Cohort A only: ER, PR negative (< 1% nuclear staining as assessed by
immunohistochemistry [IHC]), 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]); patients with concurrent bilateral invasive disease met
the inclusion criteria if both lesions were HR negative/HER2 negative.
- Cohort B only: ER, PR negative (< 1% nuclear staining as assessed by
immunohistochemistry [IHC]); 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); patients with
concurrent bilateral invasive disease met the inclusion criteria if both
lesions were HR negative/HER2 positive.
- Subjects must have positive lymph nodes or tumors > 2 cm;
- The interval between radical surgery and the first dose ≤ 60 days;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
- have appropriate organ function, meet the following criteria: (1) have appropriate
bone marrow function: Hb ≥ 100 g/L (no ESA and blood transfusion within 14 days
before the first dose); absolute neutrophil count (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); (2)
appropriate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper
limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin
(TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance >
50 ml/min (Cockcroft-Gault formula); (3) appropriate cardiac function: left
ventricular ejection fraction (LVEF) ≥ 55%;
- Non-hematologic toxicities from prior surgical procedures recovered to ≤ Grade 1 or
baseline (except alopecia);
- Females of childbearing potential agree to practice reliable contraception during
the clinical trial and have a negative serum or urine pregnancy test within 7 days
prior to dosing;
- Voluntarily join this study and sign informed consent, have good compliance and are
willing to cooperate with follow-up.
Exclusion Criteria:
- Prior neoadjuvant therapy (including chemotherapy, targeted therapy, immunotherapy,
or radiotherapy);
- History of other malignancy within 5 years prior to first dose, except basal cell
carcinoma and cervical carcinoma in situ;
- Any T4 or N2 or known N3 or M1 breast cancer;
- Subjects who cannot receive or tolerate postoperative chemotherapy for various
reasons;
- Heart disease ineligible for epirubicin, docetaxel, trastuzumab/pertuzumab:
- Any documented history of myocardial infarction, congestive heart failure
- Angina pectoris requiring antianginal medication
- Grade 3 or 4 cardiac arrhythmia (NCI CTCAEv5.0)
- Clinically significant valvular heart disease;
- Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or
diastolic blood pressure > 100 mmHg)
- Known history of hypersensitivity to the drug components of this protocol;
- Any other condition that, in the opinion of the investigator, would make the patient
inappropriate for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun-yat sen university cancer center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
shusen wang, MD
Phone:
+86-13926168469
Email:
wangshs@sysucc.org.cn
Start date:
September 20, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
wang shusen
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978648
