Trial Title:
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
NCT ID:
NCT05983094
Condition:
Breast Cancer
Neoadjuvant Therapy
Conditions: Official terms:
Breast Neoplasms
Carboplatin
Trastuzumab
Epirubicin
Pertuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Study of Utidelone based neoadjuvant treatment on early high-risk or locally advanced
breast cancer
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Utidelone
Description:
Utidelone injection 30mg/m2, on days 1-5 of each cycle
Arm group label:
cohort 1 Triple-negative breast cancer
Arm group label:
cohort 2 HR positive, HER2 negative breast cancer
Arm group label:
cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin Area under curve(AUC)6, iv, was administered on day 1
Arm group label:
cohort 1 Triple-negative breast cancer
Arm group label:
cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer
Intervention type:
Drug
Intervention name:
Epirubicin
Description:
Epirubicin 75mg/m2 was administered on day 1
Arm group label:
cohort 2 HR positive, HER2 negative breast cancer
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
Arm group label:
cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles
Arm group label:
cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer
Summary:
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone
based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced
Breast Cancer.
Detailed description:
This is a single arm, multi-center study,three-cohort, prospective phase II study which
will enroll 181 high-risk early-stage or locally advanced breast cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients who will receive initial treatment, 18-70 years of age；
2. Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced
(T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2-
T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or
Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive
(Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative
HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+;
2+, FISH amplification) breast cancer confirmed by pathological test.
3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
4. The blood routine examination was basically normal (CTCAE ≤ 1) within one week
before enrollment (based on the normal values of each research center laboratory).
No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood
transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to
enrollment.
White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) > 1.5x109 / L;
Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.
5. The blood biochemistry examination was basically normal (CTCAE ≤ 1) within one week
before enrollment (based on the normal values of each research center laboratory)
Serum total bilirubin ≤ Upper limit of normal value(ULN)； Aspartate aminotransferase
(AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN； Alkaline phosphatase ≤ 2.5×ULN；
Serum creatinine ≤ 1.5×ULN.
6. Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%
7. Female patients with fertility must agree to use effective contraceptive methods
during the study period and within 6 months of the last study medication. The
Pregnancy test (urine or serum) must be negative
8. Be willing and able to provide written informed consent/assent for the trial.
Exclusion Criteria:
1. Primary stage IV breast cancer；
2. Inflammatory breast cancer;
3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；
4. Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding
cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell
carcinoma.
5. Receive any sex hormone treatment (such as contraceptives, ovarian hormone
replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility
protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective
estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；
6. The patient has undergone major surgery unrelated to breast cancer within 4 weeks
before treatment or has not yet fully recovered;
7. Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2
8. Serious cardio cerebral Vascular disease, including but not limited to the
followings:
9. History of congestive heart failure or systolic dysfunction (LVEF<50%);
10. Angina pectoris requiring anti angina drugs;
11. High risk uncontrolled arrhythmias or severe conduction abnormalities, such as
ventricular arrhythmias that require clinical intervention, II-III degree
atrioventricular block, etc; Under resting state, the average corrected Q-T
interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms;
12. Clinically significant heart valve disease with cardiac dysfunction;
13. Hypertension that cannot be controlled;
14. History of myocardial infarction
15. Allergic to any component of any drug in this protocol.
16. Those who are not suitable for using Corticosteroid.
17. Individuals with active infections who currently require systematic anti infection
treatment.
18. History of immune deficiency disease, including positive of HIV/AIDS, or other
acquired or congenital immune deficiency diseases, or having a history of organ
transplantation.
19. Who had participated in other drug intervention clinical trials within the 28 days
of randomization, or who is participating in another clinical trial or is using
other investigational treatments.
20. Individuals in pregnancy (positive Pregnancy test) and lactation.
21. Any other comorbidities that interfere with the implementation of the treatment
plan, or the researcher evaluate that the subject has a history of other serious
systemic diseases, or other reasons lead to the patients is unsuitable to
participate in this trial.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
September 1, 2023
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Chinese Academy of Medical Sciences Cancer Hospital，Shanxi Center
Agency class:
Other
Collaborator:
Agency:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of China Medical University
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983094
