OncoMatch/Clinical Trials/NCT05420467
A Study for the Adjuvant Treatment of Breast Cancer
Is NCT05420467 recruiting? Yes, currently enrolling (Jun 2026). This Phase 4 trial studies multiple treatments for breast cancer.
Treatment: Docetaxel · Carboplatin · Trastuzumab · Pertuzumab · Nab paclitaxel · Epirubicin · Cyclophosphamide · Docetaxel · Epirubicin · Cyclophosphamide · Nab paclitaxel · Cyclophosphamide — Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression >1% (>1%)
ER/PR positive defined as stained cells >1%
Required: PR (PGR) expression >1% (>1%)
ER/PR positive defined as stained cells >1%
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with a positive FISH test)
HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test
Required: MKI67 expression level known (known)
known Ki67 expression levels
Disease stage
Required: Stage I, II, III
Excluded: Stage INOPERABLE, DISTANT METASTASIS
stage I to III breast cancer; operable primary lesion with no evidence of distant metastasis (M0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: surgery — breast cancer resection and systemic intrathoracic lymph node dissection; R0 resection
Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection
Cannot have received: paclitaxel regimen
Patients have not been treated with a paclitaxel regimen prior to enrolment
Lab requirements
Blood counts
neutrophils≥1.5×10^9/L, platelets≥100×10^9/L, hemoglobin≥90g/L
Kidney function
serum creatinine ≤1.5 times the upper limit of normal
Liver function
AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome
Cardiac function
ECG and echocardiography must confirm normal cardiac function within 3 months prior to randomization. LVEF must be ≥55% for patients receiving anthracycline-containing chemotherapy regimens and targeted therapy
Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function...LVEF must be ≥55%...serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome; neutrophils≥1.5×10^9/L, platelets≥100×10^9/L, hemoglobin≥90g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05420467 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior paclitaxel regimen disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression >1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression >1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
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 qualify