Adjuvant treatment options for breast cancer using albumin paclitaxel and docetaxel

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

This study is testing whether a new type of chemotherapy called albumin paclitaxel works better and is safer than the standard treatment docetaxel for people with different kinds of breast cancer after surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2413 (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, doxorubicin
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05420467 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of albumin paclitaxel compared to docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial. It focuses on postoperative patients with various subtypes of breast cancer, including triple-negative and HER2-positive types. The study aims to provide more realistic data on the effectiveness of these treatments and explore new options for improving patient outcomes. By analyzing the safety and tolerability of these therapies, the research seeks to enhance the quality of life and survival rates for breast cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are female patients aged 18 and older with operable stage I to III breast cancer and known hormone receptor and HER2 status.

Not a fit: Patients with distant metastasis or those who do not meet the specific inclusion criteria for breast cancer subtype 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 survival and quality of life.

How similar studies have performed: Previous studies have shown promising results with similar adjuvant therapies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged ≥18 years;
2. Histopathologically or cytologically confirmed breast cancer patients with the following characteristics:1. stage I to III breast cancer; 2. operable primary lesion with no evidence of distant metastasis (M0);
3. 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);
4. 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 adjuvant therapy, and does not represent the corresponding molecular typing definition);
5. Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection; patients who need postoperative adjuvant chemotherapy as judged by the investigator;
6. Start of adjuvant therapy within 21 days of the time of surgery is appropriate ;
7. ECOG physical fitness score of 0-1 with an expected survival of \>6 months ;
8. Patients have not been treated with a paclitaxel regimen prior to enrolment ;
9. Adjuvant chemotherapy should not be performed concurrently with endocrine therapy drugs such as tamoxifen/aromatase inhibitors or postoperative radiotherapy;
10. Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptives during the trial and 8 weeks after the last dose of the trial drug;
11. Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55% for patients receiving anthracycline-containing chemotherapy regimens and targeted therapy ;
12. 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 ;
13. Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
14. Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
15. 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 (if applicable).

Exclusion Criteria:

1. Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
2. Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
3. Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
4. The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
5. Patients with CNS metastases or \> grade 1 peripheral neuropathy;
6. Severe cardiovascular disease: Grade II or higher myocardial ischaemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound indicating a left ventricular ejection fraction (LVEF) of \<50%;
7. Patients with hypertension that cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
8. Received major surgical operations or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
9. Patients with severe myelosuppression at screening;
10. Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
11. Arterial/venous thrombotic events such as cardiovascular and cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism, that occurred within 6 months before randomization;
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; adjuvant therapy; Docetaxel; albumin paclitaxel; TCbHP; nPCbHP; ddEC-wnP