A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

Plain English Summary

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer is a Phase 3 clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. studying HER2-positive Breast Cancer. This trial tests a new drug, TQB2102, against a standard treatment (TCbHP) for HER2-positive breast cancer before surgery. It is for patients with HER2-positive invasive breast cancer that has not spread to distant organs. Participants will receive either the new drug or the standard treatment, and both are given by injection. Standard treatment options for this type of cancer include chemotherapy, targeted therapy, and surgery. The trial aims to enroll 544 participants.

Official Summary

This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with HER2-positive invasive breast cancer that has not spread to distant organs (Stage T2-4 N0 or Tany N1-3 M0) can join. Patients must have good general health and organ function, with an ECOG performance status of 0-1. Individuals with stage IV metastatic breast cancer, bilateral breast cancer, inflammatory breast cancer, or a history of other cancers within 5 years cannot participate. Those who have had prior anti-cancer treatment for breast cancer, including chemotherapy, radiation, or surgery, are also excluded. This trial is studying HER2-positive Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the treatment eliminates all signs of cancer in the breast and lymph nodes, indicating the treatment's effectiveness in clearing the disease before surgery. The specific primary outcome measures are: Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) (Up to 26 months after study start). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to find a potentially more effective treatment for HER2-positive breast cancer before surgery, addressing the need for improved outcomes in this specific patient group. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HER2-positive Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial is investigating a novel drug for a significant cancer subtype, with potential for market entry if proven superior to existing therapies, signaling a competitive landscape in HER2-positive Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 544 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific goals of neoadjuvant therapy and how TQB2102 or TCbHP might benefit you. Participation involves receiving study treatment, regular medical check-ups, and tests to monitor your response and any side effects. You will need to use effective contraception during the study and for 6 months after it ends. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 544 participants

Interventions

• DRUG: TQB2102 for injection — TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
• DRUG: Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection — TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Primary Outcomes

• Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) (Up to 26 months after study start)

Secondary Outcomes

• Rate of total physiological complete response (tpCR) evaluated by the investigator (Up to 24 months after study start)
• Breast pathological complete response (bpCR) evaluated by IRC and the investigator (Up to 26 months after study start)
• Objective response rate (ORR) (Up to 22 months after study start)
• There year Event-free survival (EFS) (Up to 50 months after study start)
• There year Invasive Disease-free survival (IDFS) (Up to 50 months after study start)

Full Eligibility Criteria

Inclusion Criteria:

* Voluntarily participate in this study, sign the informed consent form, and have good compliance;
* Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months;
* Histologically or cytologically confirmed HER2-positive invasive breast cancer;
* Hormone receptor (HR) status confirmed;
* Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;
* Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;
* Major organ function is adequate, meeting specific criteria;
* Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion

Exclusion Criteria:

* Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
* Bilateral breast cancer or inflammatory breast cancer;
* History of invasive breast cancer or ductal carcinoma in situ;
* Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;
* Comorbidities and medical history:

  * Other malignancies within 5 years or currently;
  * Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;
  * Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures;
  * Conditions affecting intravenous injection or blood sampling;
  * Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin \>325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;
  * Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;
  * Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
  * Significant cardiovascular disease, including；
  * Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;
  * History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out;
* Tumor-related symptoms and treatment:

  * Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment;
  * Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);
  * Prior taxane or carboplatin therapy for any malignancy;
  * Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.
* Study treatment-related:

  * Severe hypersensitivity to monoclonal antibodies;
  * Uncontrolled active autoimmune disease within 2 weeks before study treatment;
  * Allergy to any study drug or its components/excipients;
  * Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.
* Any condition judged by the investigator to jeopardize subject safety or study completion.

Trial Locations

• The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China
• Anhui Provincial Cancer Hospital, Hefei, Anhui, China
• The First Affiliated Hospital of Wannan Medical University, Wuhu, Anhui, China
• Peking Union Medical College Hospital, Beijing, Beijing Municipality, China
• Beijing Cancer Hospital, Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
• The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
• The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center, Chongqing, Chongqing Municipality, China
• The First Hospital Affiliated to Army Medical University, Chongqing, Chongqing Municipality, China
• Quanzhou First Hospital, Quanzhou, Fujian, China
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• HER2-Positive Breast Cancer
• Invasive Breast Cancer
• Metastatic Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• Triple-Negative Breast Cancer
• Oncology
• Medical Oncology
• Surgical Oncology
• Gynecologic Oncology

More HER2-positive Breast Cancer Trials

View all HER2-positive Breast Cancer clinical trials