OncoMatch/Clinical Trials/NCT05159193
Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer
Is NCT05159193 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: pegylated liposomal doxorubicin (PLD) · cyclophosphamide (C) · trastuzumab (H) · pertuzumab (P) · docetaxel (T) · docetaxel (T) · carboplatin (Cb) · trastuzumab (H) · pertuzumab (P) — This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (IHC 3+ or ISH positive)
HER-2 Positive (defined by IHC 3+ or ISH positive); Participants with multifocal tumors ... are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive.
Disease stage
Required: Stage CT2-CT4, CN1-CN3, CM0 (AJCC 8th Edition)
Excluded: Stage DISTANT METASTASIS
Operable breast cancer with cT2-cT4/cN1-cN3/cM0, according to the AJCC tumor staging manual (8th Edition). Breast cancer with distant metastasis [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-cancer therapy for breast cancer
Exception: participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy; in case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
Cannot have received: investigational drug
Treatment with any investigational drug within 28 days prior to randomization
Lab requirements
Blood counts
white blood cell counts ≥ 3.0x10^9/L, absolute neutrophil counts (ANC) ≥ 1.5x10^9/L, platelets ≥ 100x10^9/L, hemoglobin ≥ 90g/L
Kidney function
Serum creatinine ≤ 1.5 ULN
Liver function
ALT, AST, ALP and serum total bilirubin are all ≤2 ULN
Cardiac function
LVEF ≥ 55%; BNP (or NT proBNP) and cardiac troponin assays within normal values
LVEF ≥ 55%; BNP (or NT proBNP) and cardiac troponin assays were within normal values. ALT, AST, ALP and serum total bilirubin are all ≤2 ULN. Serum creatinine ≤ 1.5 ULN. Bone marrow function: white blood cell counts ≥ 3.0x10^9/L, absolute neutrophil counts (ANC) ≥ 1.5x10^9/L, platelets ≥ 100x10^9/L, hemoglobin ≥ 90g/L;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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