Neoadjuvant treatment for breast cancer using albumin-bound paclitaxel and docetaxel

A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer

This study is testing whether a new type of chemotherapy using albumin-bound paclitaxel works better than the standard drug docetaxel for women with early-stage breast cancer before surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1576 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy, cyclophosphamide
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05420454 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of albumin-bound paclitaxel compared to docetaxel as neoadjuvant chemotherapy for breast cancer patients. It is a prospective, randomized, open-label, multi-center study that aims to provide realistic data on treatment outcomes for different breast cancer subtypes. The study focuses on patients with unilateral primary invasive breast cancer who are eligible for systemic chemotherapy before surgery. The goal is to enhance treatment options and improve patient prognoses based on response to therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are female patients aged 18 and older with unilateral primary invasive breast cancer that is histologically confirmed and meets specific clinical criteria.

Not a fit: Patients with distant metastasis or those with breast cancer subtypes that do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new and effective treatment options for breast cancer patients, potentially improving their surgical outcomes and long-term survival rates.

How similar studies have performed: Previous studies have shown promising results with albumin-bound paclitaxel in neoadjuvant therapy, indicating that this approach has potential based on earlier findings.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged ≥18 years;
2. unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;
3. The tumor is \>2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;
4. known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells \>1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test);
5. Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor \>2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER\>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and neoadjuvant therapy, and does not represent the corresponding molecular typing definition);
6. patients who need neoadjuvant chemotherapy as judged by the investigator;
7. ECOG physical fitness score of 0-1;
8. The patient has not received any treatment for breast cancer before enrollment;
9. Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%;
10. Liver and kidney function: 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 ;
11. Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
12. Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
13. Subjects have the ability to understand, agree and sign the Informed Consent Form (ICF) for the study prior to initiating any protocol-related procedures; subjects have the ability to express consent (where applicable).

Exclusion Criteria:

1. Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
2. Patients with bilateral invasive breast cancer;
3. Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
4. Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
5. The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
6. Patients with CNS metastases or \> grade 1 peripheral neuropathy;
7. Surgical axillary staging within 6 months prior to study entry;
8. Radiotherapy, chemotherapy, biotherapy and/or endocrine therapy for currently diagnosed breast cancer prior to study entry;
9. Patients with severe myelosuppression at screening;
10. Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
11. Other concomitant diseases (e.g. untreated congenital heart disease, glomerulonephritis, etc.) which, in the opinion of the investigator, seriously endanger the safety of the patient or would prevent the implementation or completion of the programme treatment;
12. Patients with hypersensitivity to any of the components of albumin paclitaxel, epirubicin, cyclophosphamide, docetaxel, trastuzumab, and pertuzumab;
13. Patients with psychiatric disorders;
14. Subjects who are participating in another clinical study or whose first dose was administered less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose) ;
15. The investigator judges other situations that may affect the clinical research and the judgment of the research results and are not suitable for inclusion in the research.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yiding CHEN

Conditions Breast Cancer; breast cancer; neoadjuvant therapy; Docetaxel; albumin-bound paclitaxel; TCbHP; nPCbHP; ddEC-wnP