OncoMatch/Clinical Trials/NCT06202261
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Is NCT06202261 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for metastatic breast cancer.
Treatment: TQB2930 for · Paclitaxel for · TQB3616 capsule · Fulvestrant · Capecitabine tablets · Vinorelbine tartrate · Eribulin mesylate · gemcitabine hydrochloride for — This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification
Required: HER2 (ERBB2) overexpression
Required: ESR1 wild-type
Required: PR (PGR) wild-type
Disease stage
Required: Stage IV
Metastatic disease required
with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
Subjects with malignant tumors who have failed standard treatment or lack effective treatment
Cannot have received: systemic antitumor therapy
Exception: Systemic use of endocrine therapy is permitted, but not exceed 2 lines
Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines
Cannot have received: chemotherapy
Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug
Cannot have received: radiotherapy
Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug
Cannot have received: immunotherapy
Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug
Cannot have received: traditional chinese medicine with anti-tumor indications
Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose
Cannot have received: anthracycline (doxorubicin, doxorubicin liposomes)
Exception: Cumulative doses exceeded doxorubicin or doxorubicin liposomes >360 mg/m2
Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes >360 mg/m2
Cannot have received: HER2-targeted therapy
Exception: LVEF decreased to <50% or absolute LVEF decreased >15%
In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to <50% or absolute LVEF decreased >15%
Lab requirements
Blood counts
Major organs are functioning normally
Kidney function
Major organs are functioning normally
Liver function
Major organs are functioning normally
Major organs are functioning normally
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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