What is TQB2102 studying for HER2 negative breast cancer?

TQB2102 is being studied to evaluate its ability to treat HER2 negative recurrent or metastatic breast cancer. Researchers want to understand how well it works and its safety for patients whose cancer has returned or spread and who have limited treatment options. The trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Who may be eligible for this breast cancer clinical trial?

Adults aged 18 to 75 years with HER2 negative breast cancer that has recurred or spread may be eligible. Participants need a measurable tumor and must have had prior chemotherapy or specific treatments. Both men and women can join if they meet health requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses or other costs related to attending the study visits may not be covered. Participants should plan accordingly for any travel or accommodations.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID06452706

Phase II Study of TQB2102 Injection for Treating HER2 Negative Recurrent or Metastatic Breast Cancer in Adults

Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-11-19

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of TQB2102 for injection in adults aged 18 to 75 years with HER2 negative recurrent or metastatic breast cancer. This Phase II trial focuses on patients whose cancer has returned or spread and who are not suitable for surgery or radiation aimed at cure. Participants must have measurable tumors and meet certain health standards to join the study. Participants receive TQB2102 for injection, a HER2 dual-antibody-drug conjugate, given as an intravenous infusion at a dose of 7.5 mgkg every three weeks, with each treatment cycle lasting 21 days. The study follows participants for up to 48 months to assess various outcomes including tumor response, disease control, survival, and safety. Blood samples are collected at specific treatment cycles to monitor anti-drug antibodies. During the study, participants will undergo evaluations of tumor response and progression, survival, and adverse events. Safety is monitored throughout, including tests for anti-drug antibodies and circulating tumor DNA. Female participants of childbearing potential agree to use contraception during and after the study, and all participants are monitored for organ function and disease status. Follow-up continues up to four years to fully assess treatment effects and safety.

CONDITIONS

Brief Title

The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants voluntarily agree to join and sign informed consent.
Age between 18 and 75 years old.
Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less.
Diagnosed with HER2 negative breast cancer confirmed by pathology.
Evidence of local recurrence or distant metastasis not suitable for curative surgery or radiation.
Availability of sufficient tumor tissue samples for HER2 evaluation.
Prior treatment failure after at least first-line systemic chemotherapy during recurrence or metastasis.
For hormone receptor positive patients, prior failure after CDK4/6 inhibitors combined with endocrine therapy.
Disease progression or intolerance to the most recent treatment before enrollment.
At least one measurable lesion according to RECIST 1.1 criteria.
Main organs functioning within acceptable limits.
Female participants of childbearing potential must use contraception during and 6 months after study; negative pregnancy test within 7 days before enrollment; non-lactating.
Male participants must agree to use contraception during and 6 months after study.

You will not qualify if you...

History or current diagnosis of other malignant tumors within 5 years prior to first study medication.
Uncontrollable toxic reactions (above CTCAE level 1) from previous treatments.
Significant surgery or traumatic injury within 28 days before first medication.
Long-term unhealed wounds or fractures.
History or current interstitial lung disease or pneumonia requiring steroid treatment or suspected on imaging.
Arterial or venous thrombotic event within 6 months before first medication.
History of psychiatric drug abuse or mental disorders preventing quitting.
Severe or uncontrolled diseases including severe rheumatoid arthritis requiring wheelchair or bed rest.
Anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks before first medication or within 5 half-lives of previous drugs.
Use of endocrine therapy or anti-tumor traditional medicines within 2 weeks before first drug use.
Tumor invading or likely invading important blood vessels with risk of fatal bleeding.
Uncontrollable pleural effusion, ascites, or moderate to severe pericardial effusion requiring repeated drainage.
Known cancerous meningitis or active central nervous system metastasis.
Severe bone damage from tumor metastasis or unsuitable lung diseases.
Allergy to study drug, excipients, or humanized monoclonal antibody products.
Participation in other anti-tumor drug trials within 4 weeks before first medication.
Any condition judged by researchers to seriously risk safety or study completion.

Research Team

Kunwei Shen, Doctor

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Phase II Study of TQB2102 Injection for Treating HER2 Negative Recurrent or Metastatic Breast Cancer in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria