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OncoMatch/Clinical Trials/NCT06851299

The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

Is NCT06851299 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including trop2-ADC and ADC +anti-angiogenic drug for metastatic triple-negative breast cancer.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT06851299Data as of Jun 2026Location: China

Treatment: trop2-ADC · ADC +anti-angiogenic drug · ADC + PD1 monoclonal antibody +anti-angiogenic drugThis is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

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Extracted eligibility criteria

Treatments studied

Other

trop2-ADCADC +anti-angiogenic drugADC + PD1 monoclonal antibody +anti-angiogenic drug

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 70
Female only

Prior therapy

Max 2 prior lines

Cannot have received: radiotherapy

receiving radiotherapy...within 4 weeks before enrollment

Cannot have received: chemotherapy

receiving...chemotherapy...within 4 weeks before enrollment

Cannot have received: endocrine therapy

receiving...endocrine therapy within 4 weeks before enrollment

Cannot have received: interventional drug clinical trial

participating in any interventional drug clinical trial

Lab requirements

Blood counts

WBC ≥3.0×10^9 / L, ANC ≥1.5×10^9 / L, PLT ≥70×10^9 / L

Kidney function

Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min

Liver function

Total bilirubin (TBIL) ≤3× ULN; ALT/AST ≤2.5×ULN (≤5xULN in patients with liver metastases)

Cardiac function

LVEF ≥ 55%, QTcF ≤ 470 ms

adequate bone marrow reserve: a. White blood cell count (WBC) ≥3.0×10^9 / L, b. Neutrophil count (ANC) ≥1.5×10^9 / L, c. Platelet count (PLT) ≥70×10^9 / L; liver, kidney and heart function tests were basically normal (according to the normal values of the laboratories in the study center) : a. Total bilirubin (TBIL) ≤3× ULN, b. ALT/AST ≤2.5×ULN (≤5xULN in patients with liver metastases), Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min; d. LVEF ≥ 55%, e. QTcF ≤ 470 ms.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06851299 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiotherapy, chemotherapy, endocrine therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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