OncoMatch

OncoMatch/Clinical Trials/NCT05582499

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Is NCT05582499 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for breast neoplasm.

Phase 2RecruitingFudan UniversityNCT05582499Data as of Jun 2026Location: China

Treatment: Dalpiciclib · Pyrotinib · SHR-A1811 · SHR-1316 · Camrelizumab · SHR-A1921 · Pertuzumab · Trastuzumab · Goserelin · Letrozole · Nab paclitaxel · Carboplatin · Epirubicin · Cyclophosphamide · Fluzoparib · Apatinib · Famitinib · HB1801 · LEM · TQB2102 · Benmelstobart · Anlotinib · TQB2868 · Ivonescimab · JS207 · JSKN003 · HRS-4508 · SHR-4602 · paclitaxelThe purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

CamrelizumabBenmelstobartIvonescimab

Targeted therapy

DalpiciclibPyrotinibPertuzumabTrastuzumabFluzoparibApatinibFamitinibAnlotinib

Chemotherapy

Nab paclitaxelCarboplatinEpirubicinCyclophosphamidepaclitaxel

Endocrine / hormonal

GoserelinLetrozole

Other

SHR-A1811SHR-1316SHR-A1921HB1801LEMTQB2102TQB2868JS207JSKN003HRS-4508SHR-4602

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Disease stage

Required: Stage II, III

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70
Female only

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: cytotoxic chemotherapy

Previous cytotoxic chemotherapy ... for any reason

Cannot have received: endocrine therapy

Previous ... endocrine therapy ... for any reason

Cannot have received: biological therapy

Previous ... biological therapy ... for any reason

Cannot have received: radiation therapy

Previous ... radiotherapy for any reason

Lab requirements

Blood counts

Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL

Kidney function

creatinine < 1 x ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula)

Liver function

Total bilirubin ≤ 1.5 x ULN, AST (SGOT) and ALT (SGPT) ≤ 3 x ULN

Cardiac function

LVEF≥55%

Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine < 1 x ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); LVEF≥55%

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

Frequently asked questions

Is NCT05582499 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage II or III is required.

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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