Using trilaciclib for early-stage HR-negative breast cancer patients receiving chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory clinical trial evaluates the efficacy and safety of trilaciclib in patients with early-stage hormone receptor-negative breast cancer undergoing standard adjuvant chemotherapy. Participants are divided into two cohorts based on molecular typing: one for triple-negative breast cancer patients and another for HER2-positive/HR-negative patients. The primary endpoint is the incidence of grade 3/4 neutropenia, which will help determine the effectiveness of trilaciclib when administered before chemotherapy. The study aims to improve treatment outcomes for these patients by potentially reducing chemotherapy-related side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun-yat sen university cancer center
  Guangzhou, Gangdong, China Recruiting

Study contacts

• Principal investigator: Shusen Wang, MD — Sun Yat-sen University
• Study coordinator: Shusen Wang, MD
• Email: wangshs@sysucc.org.cn
• Phone: +86-13926168469

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improved Facial Skin Quality After VYC-12L for Breast Cancer Survivors

  This study tests whether intradermal injections of VYC-12L can improve facial skin quality and quality of life in adults who have completed breast cancer treatment.

  Recruiting Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Murcia, Murcia · NCT07917117

• Breast cancer subtypes and outcomes in Colombian women

  This study looks back at medical records of women with breast cancer to see how different molecular subtypes relate to survival and recurrence in a single Colombian hospital.

  Recruiting Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. · NCT07856225

• Multimodal psychosomatic symptom care for breast cancer: personalized acupuncture care guided by shared decision-making

  This study tests whether personalized acupuncture options (manual acupuncture, ear acupuncture, or both) can help women with breast cancer who have anxiety, sleep problems, or fatigue, compared to routine nursing care.

  Recruiting at 3 sites First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Tianjin and 2 other locations · NCT07763587

• Slow Jogging for Breast Cancer Survivors

  This study tests whether a 12-week slow jogging program helps sleep quality in women who have completed breast cancer treatment.

  Recruiting Mackay Memorial Hospital · Taipei, Taipei City · NCT07757763

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• Benchmarking AI language models against tumor boards for oncology treatment decisions

  This project tests whether frontier AI language models can match the treatment recommendations of multidisciplinary tumor boards for common cancers using standardized synthetic cases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Boulogne-Billancourt and 4 other locations · NCT07739121

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.