A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198751
• Other study ID #: TQB2102-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 5, 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Zhimin Shao, Doctor
• Phone: 13524514617
• Email: szm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 6.0 mg/kg of TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
• 7.5 mg/kg of TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	Harbin medical university cancer hospital	Harbin	Heilongjiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total physiological complete response (tpCR)	The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.	Up to 12 months.
Secondary	Breast pathological complete (bpCR) response	The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer.	Up to 12 months.
Secondary	Objective response rate (ORR)	The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.	Up to 12 months.
Secondary	Event-free survival (EFS)	From randomization to the first time to occurrence of the following events,including disease progression precluding surgery, ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.	Up to 60 months.
Secondary	Invasive Disease-free survival (IDFS)	From randomization to the first time to occurrence of the following events,including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.	Up to 60 months.
Secondary	The occurrence rate of all adverse events (AEs)	The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Secondary	The severity of all adverse events (AEs)	The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Secondary	Anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA)	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.