Breast NeoplasmsPhase 2SMA-BC-002NCT05978648
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
A Phase 2 study testing Trilaciclib, Epirubicin and Cyclophosphamide in people with Breast Neoplasms, run by wang shusen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Trilaciclib, Epirubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun-yat sen university cancer center
Guangzhou, Gangdong, 510060
shusen wang, MD, +86-13926168469, wangshs@sysucc.org.cn
About this study
Official title: A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer
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.
Read more
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
- Being tested
- Trilaciclib, Epirubicin, Cyclophosphamide, Paclitaxel, Docetaxel
- Keywords
- Trilaciclib; HR-Negative Breast Cancer; Adjuvant Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called COSELA®, G1T28
240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
EpirubicinDrug
90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
CyclophosphamideDrug
600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
PaclitaxelDrug
80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.
DocetaxelDrug
75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.
CarboplatinDrug
area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.
TrastuzumabDrug
8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
PertuzumabDrug
840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Triple-negative Breast Cancer | Experimental | Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP) Receives: Drug: Trilaciclib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
| Cohort B: ER-negative PR-negative Her2-positive Breast Cancer | Experimental | Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P) Receives: Drug: Trilaciclib; Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Grade 3/4 neutropenia
Proportion of subjects with at least one absolute neutrophil count (ANC) < 1.0 × 10^9/L enrolled and treated with at least one dose of trilaciclib
Measured: Up to 24 weeks
Secondary outcomes (5)
Neutrophil-related myeloprotective effects
Occurrence of febrile neutropenia adverse events(AEs) , and occurrence of Granulocyte colony-stimulating factor(G-CSF) administration
Measured: Up to 24 weeks
Red blood cell(RBC) -related myeloprotective effects
Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of erythropoiesis-stimulating agent(ESA) administration
Measured: Up to 24 weeks
Platelet-related myeloprotective effects
Occurrence of Grade 3/4 decrease of platelets, occurrence and number of platelet transfusions, and occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration
Measured: Up to 24 weeks
Myeloprotective Effects
Hospitalization due to chemotherapy-induced myelosuppression, dose reductions and delays, relative dose intensity(RDI) of chemotherapeutic agents
Measured: Up to 24 months
Safety and tolerability
Incidence of Treatment-Emergent Adverse Events as per CTCAE version 5.0
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start20 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang shusen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang shusen, Sun Yat-sen University
- Investigators
- Shusen Wang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978648
- Sponsor's protocol ID
- SMA-BC-002
- Acronym
- SMA-BC-002
- Status last verified
- Nov 2023
- First submitted
- 18 Jul 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05978648
- Acronym / sponsor ID
- SMA-BC-002 / SMA-BC-002
- Conditions
- Breast Neoplasms
- Keywords
- Trilaciclib; HR-Negative Breast Cancer; Adjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- wang shusenUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Triple-negative Breast Cancer | Experimental | Drug: Trilaciclib, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: PaclitaxelCohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP) |
| Cohort B: ER-negative PR-negative Her2-positive Breast Cancer | Experimental | Drug: Trilaciclib, Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: PertuzumabCohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age ≥ 18 years;
- breast cancer meets the following criteria:
- 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);
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrilaciclibAlso: COSELA®, G1T28240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day | Drug | Cohort A: Triple-negative Breast Cancer, Cohort B: ER-negative PR-negative Her2-positive Breast Cancer |
| Epirubicin90 mg/m2, intravenous drip, d1, Q3W, 4 cycles. | Drug | Cohort A: Triple-negative Breast Cancer |
| Cyclophosphamide600 mg/m2, intravenous drip, d1, Q3W, 4 cycles. | Drug | Cohort A: Triple-negative Breast Cancer |
| Paclitaxel80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles. | Drug | Cohort A: Triple-negative Breast Cancer |
| Docetaxel75 mg/m2, intravenous drip, d1, Q3W, 6 cycles. | Drug | Cohort B: ER-negative PR-negative Her2-positive Breast Cancer |
| Carboplatinarea under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles. | Drug | Cohort B: ER-negative PR-negative Her2-positive Breast Cancer |
| Trastuzumab8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year. | Drug | Cohort B: ER-negative PR-negative Her2-positive Breast Cancer |
| Pertuzumab840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year. | Drug | Cohort B: ER-negative PR-negative Her2-positive Breast Cancer |
Primary outcome
Occurrence of Grade 3/4 neutropenia
Time frame: Up to 24 weeks
Proportion of subjects with at least one absolute neutrophil count (ANC) < 1.0 × 10^9/L enrolled and treated with at least one dose of trilaciclib
5 secondary outcomes
Neutrophil-related myeloprotective effects
Time frame: Up to 24 weeks
Red blood cell(RBC) -related myeloprotective effects
Time frame: Up to 24 weeks
Platelet-related myeloprotective effects
Time frame: Up to 24 weeks
Myeloprotective Effects
Time frame: Up to 24 months
Safety and tolerability
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shusen Wang, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib, Epirubicin and Cyclophosphamide in people with Breast Neoplasms, run by wang shusen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shusen Wang, MD (+86-13926168469, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Grade 3/4 neutropenia (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.