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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05159193 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.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT2-CT4 or CN1-CN3 or CM0 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.
Check if I qualifyRelated pages