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New treatment option for Breast Neoplasms
Official title Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT05978648
What this study is testing
What is Trilaciclib?
Trilaciclib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for breast neoplasms.
Also referred to as COSELA®, G1T28.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cohort B only: ER, PR negative (\< 1% nuclear staining as assessed by immunohistochemistry [IHC]); HER2 positive: HER2/CEP17 ratio ≥ 2.0 or HER2 gene...
You likely can't join if
- 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;
- people 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
See the full eligibility 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...
- 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...
- people 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)...
- 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.
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Gangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Gangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.