AzTrials
AzTrials

HER2-positive Breast CancerPhase 3NCT05985187

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.

A Phase 3 study testing TQB2440 injection + Trastuzumab + Docetaxel and Perjeta + Trastuzumab + Docetaxel in people with HER2-positive Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
TQB2440 injection + Trastuzumab + Docetaxel and Perjeta + Trastuzumab + Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
6 sitesChina
Study dates
20 Oct 2020to Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 22Show fewer
  • 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:
  • Blood routine test criteria (no blood transfusion within 7 days prior to screening, no hematopoietic stimulant drug correction):
  • Hemoglobin (HGB) ≥90g/L;
  • Neutrophil absolute value (NEUT) ≥1.5×10^9/L;
  • Platelet count (PLT) ≥ 100×10^9/L;
  • Leukocyte ≥2.5×10^9/L;
  • Biochemical tests must meet the following criteria:
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  • Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN.
  • Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥50 ml/min (creatinine clearance calculated according to Cockcroft-Gault formula);
  • The coagulation function test should meet the following criteria:
  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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:
  • 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);
  • Heart failure or systolic dysfunction (LVEF < 55%) diagnosis history;
  • 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);
  • Angina pectoris requiring treatment with anti-angina medication;
  • Valvular heart disease of clinical significance;
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

  • Sun Yat-sen University Cancer Prevention Center

    Guangzhou, Guangdong, 150001

  • Affiliated cancer hospital of harbin medical university

    Harbin, Heilongjiang, 150001

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality, 300201

  • The First Affiliated Hospital of PLA Air Force Medical University

    Xi'an, Shaanxi, 710000

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical 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.

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.

Being tested
TQB2440 injection + Trastuzumab + Docetaxel, Perjeta + Trastuzumab + Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2440 injection + Trastuzumab + DocetaxelDrug

    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.

  • Perjeta + Trastuzumab + DocetaxelDrug

    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.

Study groups in NCT05985187
Study groupRoleWhat they receive
TQB2440 injection + Trastuzumab + docetaxelExperimentalNeoadjuvant phase (cycle 1-4): TQB2440 injection + Trastuzumab + Docetaxel, intravenous infusion on the first day of each cycle, each cycle is 21 days. Adjuvant chemotherapy phase (cycle 5-7): Fluorouracil (600 mg/m2)+Epirubicin (90 mg/m2)+Cyclophosphamide (600mg/m2), intravenous injection once a day, on the first day of each cycle, each cycle is 21 days. Double targeted maintenance phase (cycle 8-20): TQB2440 injection+Trastuzumab, intravenous infusion on the first day of each cycle, each cycle is 21 days.
Receives: Drug: TQB2440 injection + Trastuzumab + Docetaxel
Perjeta® + Trastuzumab + docetaxelActive comparatorNeoadjuvant phase (cycle 1-4): Perjeta® (Pertuzumab injection) + Trastuzumab + Docetaxel, intravenous infusion on the first day of each cycle, each cycle is 21 days. Adjuvant chemotherapy phase (cycle 5-7): Fluorouracil (600 mg/m2)+Epirubicin (90 mg/m2)+Cyclophosphamide (600mg/m2), intravenous injection once a day, on the first day of each cycle, each cycle is 21 days. Double targeted maintenance phase (cycle 8-20): TQB2440 injection+Trastuzumab, intravenous infusion on the first day of each cycle, each cycle is 21 days.
Receives: Drug: Perjeta + Trastuzumab + Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall pathological complete response (tpCR) rate assessed by Independent review committee (IRC).

    Percentage of subjects with tumor shrinkage reached a complete response assessed by the IRC, defined as no invasive tumor cells in breast and axilla after primary tumor resection.

    Measured: Baseline up to 4 months.

Secondary outcomes (9)

  1. tpCR rate evaluated by the investigators.

    Percentage of subjects with tumor shrinkage reached a complete response assessed by the investigators, defined as no invasive tumor cells in breast and axilla after primary tumor resection.

    Measured: Baseline up to 4 months.

  2. Breast pathological complete response (bpCR) rate evaluated by the investigators.

    It is defined as no invasive tumor cells in breast examined by microscopy after primary tumor resection, as assessed by the investigators.

    Measured: Baseline up to 4 months.

  3. bpCR assessed by IRC.

    It is defined as no invasive tumor cells in breast examined by microscopy after primary tumor resection, as assessed by the IRC.

    Measured: Baseline up to 4 months.

  4. Breast conservation rate

    Proportion of patients undergoing breast preservation surgery.

    Measured: Baseline up to 5 months.

  5. Objective remission rate (ORR)

    The optimal ORR evaluated by the investigator, including cases with complete response (CR) and partial response (PR).

    Measured: Baseline up to 2 years.

  6. Event-free survival (EFS)

    EFS refers to the time interval from randomization to the first recording of the following events: Preoperative disease progression as measured by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Baseline up to two years.

  7. Disease free survival (DFS)

    DFS refers to the interval between the first day of absence of disease and the first recording of postoperative recurrence of disease or death from any cause, whichever comes first.

    Measured: Baseline up to 2 years.

  8. Overall Survival (OS)

    OS indicates the time interval from randomization to death from any cause.

    Measured: Baseline up to 2 years.

  9. Incidence of adverse events

    It refer to all adverse medical events that occur after patients or subjects receives an investigational drug, including adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start20 Oct 2020
  3. Primary completion8 Jan 2023
  4. Study completionDec 2023 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985187
Sponsor's protocol ID
TQB2440-III-01
Status last verified
Apr 2023
First submitted
3 Aug 2023
Last updated
14 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu D, Wu J, Yu J, Yang Y, Wen X, Yang J, Wei H, Xu X, Li Y, Yang L, Wang L, Wang Y, Ma W, Li N. A historical controlled study of domestic trastuzumab and pertuzumab in combination with docetaxel for the neoadjuvant treatment of early HER2-positive breast cancer. Front Oncol. 2024 Feb 9;14:1281643. doi: 10.3389/fonc.2024.1281643. eCollection 2024.

    PubMed 38406813

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2440 injection + Trastuzumab + Docetaxel and Perjeta + Trastuzumab + Docetaxel in people with HER2-positive Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites 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 22 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall pathological complete response (tpCR) rate assessed by Independent review committee (IRC). (time frame: Baseline up to 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05985187, which also lists 1 linked publication.

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 14 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in