Clinical trial NCT06198751: A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
Official title: A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Voluntarily participate in this study and sign informed consent;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
* Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
* Confirmed as HER2 positive;
* Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
* Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
* Major organ functions are good, meeting certain criteria;
* Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.

Exclusion Criteria:

* IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
* Bilateral invasive breast cancer.
* Coexisting diseases and medical history:

  1. History of invasive breast cancer.
  2. Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
  3. Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
  4. Unhealed wounds or fractures.
  5. Ocular diseases deemed clinically significant by the investigator.
  6. Occurrence of arterial/deep venous thrombotic events within the last 6 months.
  7. History of substance abuse with inability to quit or individuals with mental disorders.
  8. ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
  9. Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
  10. History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.
* Tumor-related symptoms and treatment:

  1. Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
  2. Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
  3. Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.
* Study treatment-related:

  1. Experienced severe hypersensitivity reactions after using monoclonal antibodies.
  2. Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
  3. Allergic to any component or excipient in any study drug.
* Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
* Deemed inappropriate for inclusion based on the investigator's judgment.

Primary outcomes:
measure: Total physiological complete response (tpCR)
timeFrame: Up to 12 months.
Secondary outcomes:
measure: Breast pathological complete (bpCR) response
timeFrame: Up to 12 months.
measure: Objective response rate (ORR)
timeFrame: Up to 12 months.
measure: Event-free survival (EFS)
timeFrame: Up to 60 months.
measure: Invasive Disease-free survival (IDFS)
timeFrame: Up to 60 months.
measure: The occurrence rate of all adverse events (AEs)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: The severity of all adverse events (AEs)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Anti-drug antibody (ADA)
timeFrame: 1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Harbin
country: China
facility: Harbin medical university cancer hospital
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: