A Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer

August 19, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer

The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

542

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
      • Hefei, Anhui, China, 230000
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China, 230000
        • AnHui Province Hospital West District
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
        • Contact:
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Fujian Medical University 2nd Affiliated Hospital
        • Contact:
      • Zhangzhou, Fujian, China, 363000
        • Zhangzhou Hospital in Fujian Province
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Gansu Provincial Hospital
      • Lanzhou, Gansu, China, 730050
        • Gansu Provincial Cancer Hospital
        • Contact:
        • Contact:
      • Wuwei, Gansu, China, 730000
        • Gansu Wuwei Tumour Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yet-Sen University Cancer Certer
        • Contact:
      • ZhanJiang, Guangdong, China, 524001
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
    • Guangxi
      • Guigang, Guangxi, China, 537100
        • Guigang City People's Hospital
        • Contact:
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Cancer Hospital Affiliated to Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
      • Guiyang, Guizhou, China, 550000
        • The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
        • Contact:
      • Haikou, Hainan, China, 570102
        • The First Affiliated Hospital Of Hainan Medical College
        • Contact:
    • Hebei
      • Baoding, Hebei, China
        • Affiliated Hospital of Hebei University
        • Contact:
          • Hua Yang, Doctor
          • Phone Number: 18603120729
          • Email: docyh@163.com
      • Chengde, Hebei, China, 067024
        • Chengde Central Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China, 455100
        • Anyang Tumor Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Henan Cancar Hospital
        • Contact:
    • Hennan
      • Luoyang, Hennan, China, 471003
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
        • Contact:
      • Wuhan, Hubei, China, 430034
        • Tongji Hospital Tongji Medical College of HUST
        • Contact:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 24099
        • Chifeng Municipal Hospital
        • Contact:
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The Second Hospital of Dalian Medical University
        • Contact:
    • Shandong
      • Binzhou, Shandong, China, 256699
        • Binzhou Medical College Affiliated Hospital
        • Contact:
      • Binzhou, Shandong, China, 310053
        • Binzhou People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200082
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
    • Shanxi
      • Baoji, Shanxi, China, 721008
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Affiliated Hospital of North Scichuan Medical College
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310004
        • Affiliated Hangzhou First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects voluntarily enrolled in this study with good compliance;
  • Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1;
  • Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:
  • Defined hormone receptor (HR) status.
  • Imaging-confirmed disease progression (during or after completion of the most recent treatment);
  • Have at least one measurable lesion according to RECIST 1.1 criteria;
  • Good major organ function.

Exclusion Criteria:

  • The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ;
  • Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 due to any prior therapy;
  • Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the pre-randomization period;
  • Prolonged unhealed wounds or fractures;
  • Previous history of interstitial lung disease/pneumonia requiring steroidal drug intervention;
  • The presence of moderate to severe pulmonary dysfunction/disease within 3 months prior to randomization;
  • The presence of an arterial/deep vein thrombotic event within 6 months prior to randomization;
  • The presence of a medical condition that interferes with intravenous administration, intravenous blood collection, or inability to swallow, chronic diarrhea, intestinal obstruction, or the presence of other factors that interfere with the administration and absorption of medications;
  • The presence of grade ≥2 myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QT corrected (QTc) ≥450ms (men) and QTc ≥470ms (women)) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); angina pectoris requiring antianginal medication; and clinically significant heart valve disease;
  • Active or uncontrolled ≥ CTC AE grade 2 infection present within 14 days prior to randomization;
  • Cirrhosis of the liver, active hepatitis that is not well controlled;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • History of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
  • Those with routine urinalysis suggestive of urinary protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
  • Those who have used immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization;
  • Those with a history of psychotropic substance abuse that cannot be abstained from or those with psychiatric disorders;

  • Tumor-related symptoms and treatments:

    1. Subjects who have been treated with other antineoplastic agents such as chemotherapy, radical radiotherapy, or immunotherapy within 4 weeks prior to randomization, or who are still within 5 half-lives of the drug (whichever occurs shortest);
    2. Treatment with endocrine therapy, molecularly targeted therapy, or a proprietary Chinese medicine with an anti-tumor indication as specified in the National Medical Products Administration (NMPA) approved drug insert within 2 weeks prior to randomization;
    3. Presence of carcinomatous lymphadenitis, or uncontrollable pleural effusion, ascites, and pericardial effusion of moderate volume or greater that requires repeated drainage to relieve clinical symptoms, or who have received drainage of plasmapheresis for therapeutic purposes within 2 weeks prior to randomization;
    4. Known carcinomatous meningitis or clinically active central nervous system metastases;
    5. Severe bone damage resulting from tumor bone metastases;
  • Those who have received a control chemotherapeutic agent of the investigator's choice during the recurrent metastatic phase or for whom a control chemotherapeutic agent of the investigator's choice is inappropriate for reasons such as intolerance or contraindication to that agent;
  • Has received prior anti-HER2 therapy;
  • Who have developed hypersensitivity to humanized monoclonal antibody products;
  • Those who have developed an allergy to any of the study drugs or any component or excipient in the drugs;
  • Who have participated in and used another antitumor clinical trial drug within 4 weeks prior to randomization;
  • Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or who are deemed to have other reasons for being unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for Injection
Administered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle.
Drug: TQB2102 for Injection
TQB2102 is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug proposed for patients with HER2 low-expressing breast cancer.
Active Comparator: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment.

  • Capecitabine
  • Paclitaxel
  • Albumin Paclitaxel
Drug: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs for treatment.

  • Capecitabine: 1000-1250 mg/m2 twice daily, administered consecutively on day 1-14, 21 days as a treatment cycle.
  • Paclitaxel: 175 mg/m2, IV infusion, administered Day1 per cycle, 21 days as a treatment cycle. OR 80 mg/m2 by IV infusion administered weekly.
  • Albumin Paclitaxel: 260 mg/m2, IV infusion, administered every cycle of Day1 for 21 days as a treatment cycle. 100 mg/m2 or 125 mg/m2, IV infusion, administered every cycle of Day 1 and Day 8 for 21 days as a treatment cycle; or Day 1, Day 8, and Day 15 administered every cycle for 28 days as a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
Time Frame: Up to 25 months
Designed to demonstrate that in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.
Up to 25 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC
Time Frame: Up to 25 months
Designed to demonstrate that in subjects with HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.
Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time Frame: Up to 25 months
To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population.
Time Frame: Up to 25 months
To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time Frame: Up to 25 months
To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time Frame: Up to 25 months
To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Investigator-assessed clinical benefit rate (CBR) in the HR-positive, low HER2-expressing population
Time Frame: Up to 25 months
To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HER2 low expression population
Time Frame: Up to 25 months
To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Overall survival (OS) as assessed by investigators in the HER2 low expression population
Time Frame: Up to 25 months
To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HER2 low expression population
Time Frame: Up to 25 months
To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Objective remission rate (ORR) as assessed by investigators in the HER2 low expression population
Time Frame: Up to 25 months
To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Clinical benefit rate (CBR) as assessed by investigators in the HER2 low expression population
Time Frame: Up to 25 months
To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Up to 25 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
Time Frame: Up to 52 months
To evaluate the safety of TQB2102 for Injection compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).
Up to 52 months
Blood concentrations of the ADC drug TQB2102, total antibodies, and the small molecule toxin TQ22723
Time Frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle).

To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.

Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 .
Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle).
Immunogenicity of TQB2102: ADA incidence
Time Frame: Prior to (-60 min) the first day of dosing in Cycle 1, Cycle 2, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle), and at follow-up 30 days (±7 days) after the last dosing.
To evaluate the immunogenicity (ADA) of TQB2102 for injection in subjects with HER2 low expression recurrent/metastatic breast cancer.
Prior to (-60 min) the first day of dosing in Cycle 1, Cycle 2, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle), and at follow-up 30 days (±7 days) after the last dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2102-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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