Trial Title:
Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.
NCT ID:
NCT05985187
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Trastuzumab
Pertuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2440 injection + Trastuzumab + Docetaxel
Description:
TQB2440 injection is a biosimilar of Perjeta® (Pertuzumab injection) developed by Chia
Tai Tianqing Pharmaceutical Group. Trastuzumab is a recombinant DNA-derived human IgG
monoclonal antibody against P185 glycoprotein regulated by HER2 gene in cell nucleus.
Docetaxel is a selective L-type calcium channel blocker.
Fluorouracil + epirubicin + cyclophosphamide for 3 cycles is a routine chemotherapy
method after neoadjuvant surgery for breast cancer.
The combination of Pertuzumab and Trastuzumab will enhance the antitumor activity and is
used as the double targeted maintenance.
Arm group label:
TQB2440 injection + Trastuzumab + docetaxel
Intervention type:
Drug
Intervention name:
Perjeta + Trastuzumab + Docetaxel
Description:
Perjeta® with the general name Pertuzumab injection, is a recombinant humanized
monoclonal antibody targeting the extracellular second domain of human epidermal growth
factor receptor 2 (HER2). Trastuzumab is a recombinant DNA-derived human IgG monoclonal
antibody against P185 glycoprotein regulated by HER2 gene in cell nucleus. Docetaxel is a
selective L-type calcium channel blocker.
Fluorouracil + epirubicin + cyclophosphamide for 3 cycles is a routine chemotherapy
method after neoadjuvant surgery for breast cancer.
The combination of Pertuzumab and Trastuzumab will enhance the antitumor activity and is
used as the double targeted maintenance.
Arm group label:
Perjeta® + Trastuzumab + docetaxel
Summary:
This is a multicenter, randomized, double-blind, parallel-controlled Phase III study to
evaluate the efficacy and safety of TQB2440 injection/Perjeta® combined with trastuzumab
and docetaxel in patients with early or locally advanced ER/ PR-negative HER2-positive
breast cancer. The trial is scheduled to enroll 412 participants. The sample size was
estimated based on 20 treatment cycles and 6 recurrence visits.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent, and the
compliance was good;
- Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative
Oncology Group Physical condition scoring criteria score: 0-1; Survival is expected
to exceed 3 months;
- Patients with primary breast cancer confirmed by histopathology or cytology；
- Primary tumor diameter > 2 cm measured by local standard assessment method, or lymph
node positive lesions confirmed by clinical or imaging examination;
- The investigators determined that this was consistent with the American Joint
Committee on Cancer (AJCC) 8th Edition of breast cancer Tumor Node Metastasis stage
II-III C (T2-T4 plus any N, or any T plus N1-3, M0) and histologically proven
invasive breast cancer. A patient with invasive breast cancer must have a solid
lesion capable of coarse needle biopsy;
- Laboratory tests confirmed HER2 positive, defined as a 3+ immunohistochemical result
or a positive Fluorescence in situ hybridization double probe (2018 edition of
American Society of Clinical Oncology/College of American Pathologists HER2 Testing
Guidelines)
- The confirmed estrogen receptor (ER) and progesterone receptor (PgR) were negative;
- The patient agrees to undergo a mastectomy when surgical criteria are met after
neoadjuvant therapy;
- Major organs function well, meeting the following criteria:
1. Blood routine test criteria (no blood transfusion within 7 days prior to
screening, no hematopoietic stimulant drug correction):
1. Hemoglobin (HGB) ≥90g/L;
2. Neutrophil absolute value (NEUT) ≥1.5×10^9/L;
3. Platelet count (PLT) ≥ 100×10^9/L;
4. Leukocyte ≥2.5×10^9/L;
2. Biochemical tests must meet the following criteria:
1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN.
3. Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥50 ml/min
(creatinine clearance calculated according to Cockcroft-Gault formula);
3. The coagulation function test should meet the following criteria:
1. Prothrombin time (PT), activated partial thromboplastin time (APTT),
International Normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy),
if the patient is receiving anticoagulant therapy, as long as the PT is
within the intended range of anticoagulant drug use;
- For women who are not menopausal (menopause is defined as non-treaty-induced
menopause for ≥12 months) or who are not surgically sterilized (removal of ovaries
and/or uterus): Consent is required to remain abstinent during treatment and for at
least 7 months after the last study treatment, or to take a single or combined
annual failure rate of < 1% of non-hormonal contraception;
- For women of childbearing age, premenopausal or postmenopausal abstinence of less
than 12 months, and who have not been surgically sterilized, serological pregnancy
tests are negative.
Exclusion Criteria:
- Patients with stage IV metastatic breast cancer or other cancers that investigators
determined could not be radically removed by neoadjuvant therapy;
- Bilateral invasive breast cancer;
- Patients with breast cancer who have previously received anti-tumor therapy, such as
chemotherapy, endocrine therapy or anti-HER2 biotherapy, or who have undergone
breast surgery (other than diagnostic biopsies for primary breast cancer);
- Occurred or present with other malignant tumors within 3 years. Patients with the
following two conditions can be enrolled: other malignancies treated with a single
operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical
carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta
(non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal
membrane)];
- Major surgical treatment, open biopsy, or significant traumatic injury (except for
diagnostic biopsies for primary breast cancer) received within 28 days before the
start of study treatment;
- A wound or fracture that has not healed for a long time.
- Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident
(including temporary ischemic attack, cerebral hemorrhage, cerebral infarction),
deep vein thrombosis and pulmonary embolism;
- Subject who have a history of psychotropic substance abuse and are unable to abstain
or have mental disorders;
- Subjects with any severe and/or uncontrolled disease, including:
1. Patients with a history of critical hypertension or hypertensive
encephalopathy; Or uncontrolled high blood pressure (systolic blood pressure
>150 mmHg after taking antihypertensive drugs, or diastolic blood pressure >100
mmHg);
2. Heart failure or systolic dysfunction (LVEF < 55%) diagnosis history;
3. Have grade 2 myocardial ischemia or myocardial infarction, arrhythmia
(including QTc ≥450 ms in men, QTc ≥470 ms in women, and grade 2 congestive
heart failure (NYHA rating);
4. Angina pectoris requiring treatment with anti-angina medication;
5. Valvular heart disease of clinical significance;
6. Screening period confirmed hepatitis C virus (HCV) positive, human
immunodeficiency virus (HIV) positive, syphilis treponema specific antibody
positive, HBsAg positive and peripheral blood hepatitis B virus DNA (HBV DNA)
titer beyond the normal range;
- Within 2 weeks before the start of the study treatment, the patients were treated
with Chinese patent medicines (including compound Cantharides capsule, Kangai
injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil
injection/capsule, Xiaoaiping tablet/injection, Cinobufacini capsule, etc.) which
had clear anti-tumor indications in the China National Medicinal Products
Administration (NMPA) approved drug label;
- Patients whose imaging (Computed Tomography or Magnetic Resonance Imaging) shows
that the tumor has invaded an important blood vessel or who are judged by the
investigator to be highly likely to invade an important blood vessel during
subsequent studies and cause a fatal hemorrhage;
- Active autoimmune disease requiring systemic treatment (such as use of
disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2
years prior to study treatment initiation. Replacement therapies (such as thyroxine,
insulin, or physiological corticosteroids for adrenal or pituitary insufficiency)
are not considered systemic;
- Subjects diagnosed with immune deficiency or is receiving systemic glucocorticoid
therapy or any other form of immunosuppressive therapy. (Dose >10mg/ day of
prednisone or other therapeutic hormone) and continued use within 2 weeks of initial
administration;
- Other comorbidities that interfere with planned treatment include severe lung
dysfunction/disease, active or uncontrolled severe infection (≥ Common Terminology
Criteria for Adverse Events (CTCAE) Version 5.0 grade 2 infection)
- Allergy to any investigational drug or any ingredient or excipient in the drug;
- Subjects had participated in clinical trials of other antineoplastic drugs within 4
weeks before the group;
- Participants who, in the investigator's judgment, have a concomitant medical
condition that seriously endangers the safety of the subjects or interferes with the
completion of the study, or who are deemed unsuitable for enrollment for other
reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400000
Country:
China
Facility:
Name:
Sun Yat-sen University Cancer Prevention Center
Address:
City:
Guangzhou
Zip:
150001
Country:
China
Facility:
Name:
Affiliated cancer hospital of harbin medical university
Address:
City:
Harbin
Zip:
150001
Country:
China
Facility:
Name:
The First Affiliated Hospital of PLA Air Force Medical University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Hospital
Address:
City:
Tianjin
Zip:
300201
Country:
China
Start date:
October 20, 2020
Completion date:
December 2023
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05985187
