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

Recruiting Phase 3 Interventional Study
HER2-positive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
544 (estimated)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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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 breas…
Contacts

Zhimin Shao, Doctor

13524514617

szm@163.com

CONTACT

Caigang Liu, Doctor

18940256668

zlzxlcsy@163.com

CONTACT