Trial Title:
Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
NCT ID:
NCT05673629
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Utidelone Injection in combination with AC
Description:
The treatment group will be treated with Utidelone Injection at 30 mg/m2/d administered
intravenously once daily on days 1-5 of each cycle, and Doxorubicin Injection at 50mg/m2
and Cyclophosphamide Injection at 500 mg/m2, administered intravenously respectively once
daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in
total.
After the neoadjuvant therapy, all patients suitable for surgery will have the operation,
and they will be evaluated pre-operatively for clinical remission according to RECIST
1.1. For patients unsuitable for surgery, they will receive other treatments according to
the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be
followed up for at least 3 years for disease recurrence.
Arm group label:
The treatment group-Utidelone in combination with AC
Intervention type:
Drug
Intervention name:
Docetaxel Injection in combination with AC
Description:
The control group will be treated with Docetaxel Injection at 75 mg/m2, Doxorubicin
Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered
intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles
in total.
After the neoadjuvant therapy, all patients suitable for surgery will have the operation,
and they will be evaluated pre-operatively for clinical remission according to RECIST
1.1. For patients unsuitable for surgery, they will receive other treatments according to
the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be
followed up for at least 3 years for disease recurrence.
Arm group label:
The control group-Docetaxel in combination with AC
Summary:
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone
plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative
early-stage or locally advanced breast cancer.
In this phase III, multi-center, open-label, randomized controlled study, 552 subjects
will be enrolled and randomly assigned in a 1:1 ratio to either the Utidelone plus AC
group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or
PgR positive vs ER and PgR negative).
Detailed description:
The subjects in treatment group will be treated with Utidelone at 30 mg/m2/d administered
intravenously once daily on days 1-5 of each cycle, and doxorubicin at 50mg/m2 and
cyclophosphamide at 500 mg/m2, administered intravenously once daily on day 1 of each
cycle. One treatment cycle has 21 days, and there are in total 6 cycles. The subjects in
control group will be treated with docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and
cyclophosphamide at 500mg/m2, administered intravenously once on day 1 of each cycle. One
cycle has 21 days, and there are 6 cycles in total.
After the neoadjuvant therapy, all patients suitable for surgery should take the
operation, and patients will be evaluated pre-operatively for clinical remission
according to RECIST 1.1. After the surgery, patients will be evaluated for pathological
remission, and physicians will recommend, according to clinical practice guidelines and
clinical practice at each site, radiotherapy or adjuvant therapy for patients with
corresponding clinical indications, and endocrine therapy for ER positive and/or PgR
positive patients. Patients unsuitable for surgery receive other treatments according to
the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be
followed up for at least 3 years for disease recurrence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients who will receive initial treatment, 18 ≤ years of age ≤70.
2. Pathologically confirmed HER2-negative breast cancer at each investigational site
with IHC at 0 or 1+, or IHC at 2+ with HER2 being negative by ISH (please refer to
the ASCO/CAP Guideline 2020 for the relevant definition).
3. For patients with triple negative breast cancer, the requirement is tumor size>2 cm
or lymph node-positive (T1, N1-3, M0, T2-4, any N, M0; tumor stage: II or III).
4. For patients with HR-positive and HER2-negative breast cancer, the requirement is
(T2-4, N1-3, M0 or T2-4, N0 with high risk factors, M0):
- Tumor size>2cm
- lymph node-positive or high-risk factor with pathologically negative lymph
node. High risk factors include:
A. histologic grade 3.
B. high Ki67 expression (≥20%).
5. Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE
grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no
blood transfusion/EPO etc. within 14 days prior to enrollment.
A. White blood cell count ≥ 4.0× 109/L;
B. Neutrophil count ≥ 1.5 × 109/L;
C. Platelet count ≥ 100 × 109/L;
D. Hemoglobin ≥100 g/L.
6. Blood biochemistry test result is normal within 1 week prior to enrollment, with
CTCAE grade ≤1 (based on normal values at each site's laboratory).
A. Total bilirubin ≤ upper limit of normal (ULN).
B. AST and ALT ≤ 1.5 x ULN.
C. alkaline phosphatase ≤ 2.5×ULN.
D. Serum creatinine ≤ 1.5×ULN.
7. Left ventricular ejection fraction (LVEF) on cardiac ultrasound ≥55%.
8. ECOG performance status 0 or 1.
9. Females of childbearing potential must agree to use effective contraception during
the study and within 6 months after the last dose. The blood or urine pregnancy test
for female patients of childbearing age prior to enrollment must be negative.
10. The patient willingly participates in this study, will sign the informed consent
form, and commits to following the treatment and follow-up schedule.
Exclusion Criteria:
1. Stage IV metastatic breast cancer.
2. Inflammatory breast cancer.
3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
4. Patients who have previously received anti-tumor treatment or radiotherapy for any
malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma of the
skin and squamous cell carcinoma.
5. Patients who receive any sex hormone therapy (e.g., birth control pills, hormone
replacement therapy, etc.), or any hormonal drug (e.g., raloxifene, tamoxifen, or
other selective estrogen receptor modulators) for osteoporosis or breast cancer
prevention.
6. Patients received major surgical operation unrelated to breast cancer within 4 weeks
prior to randomization or having not yet fully recovered.
7. Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥ 2.
8. Patients with severe cardiovascular diseases, including but not limited to:
A. history of congestive heart failure or systolic dysfunction (LVEF < 50%).
B. angina requiring anti-anginal medication.
C. high-risk uncontrolled arrhythmias or severe conduction abnormalities, such as
ventricular arrhythmias requiring clinical intervention, second- to third-degree
atrioventricular block, etc.; mean QTcF >470ms in 3 12-lead ECGs tests at rest.
D. clinically significant heart valve disease with impaired cardiac function.
E. Clinically uncontrollable hypertension.
F. History of myocardial infarction.
9. Patients allergic to any ingredient of any drug to be administered in this study.
10. Patients unsuitable for corticosteroids.
11. Patients with active infection and currently in need of systemic anti-infective
therapy.
12. Patients with history of immunodeficiency, including history of HIV, or other
acquired or congenital immunodeficiency disease, or a history of organ
transplantation.
13. Patients who have participated in another interventional drug trial within 28 days
prior to randomization or are concurrently participating in another clinical trial
or using another investigational treatment.
14. Patients during pregnancy (positive pregnancy test), lactation.
15. Patients with any other co-morbidities that interfere with the regimens in this
study, or in the opinion of the investigator, the subject has a history of other
serious systemic disease or other reasons that make participation in this trial
inadvisable.
Gender:
Female
Gender based:
Yes
Gender description:
Female patients who will receive initial treatment, 18 ≤years of age ≤70.
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
zhimin shao
Start date:
May 30, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Beijing Biostar Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Beijing Biostar Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673629
