Clinical trial NCT05251766: Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
Official title: Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Chemotherapy Effect
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer

Detailed description: 1. To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; 2. To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with human epidermal growth factor receptor 2(HER2)-negative breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Female patients with age range ≥ 18 years;
2. a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
3. HER2 negative breast cancer, tumor \>2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
4. Known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]), known Ki67 value;
5. Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
6. patients have not previously had breast cancer treatment.
7. During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
8. Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
9. Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet（PLT）≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase（ALT） ≤ 3 times of the upper limit of normal).

Exclusion Criteria:

1. bilateral invasive breast cancer, metastatic disease or other malignant tumors.
2. Surgical axillary staging surgery was performed within 6 months before entering the study;
3. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
4. before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
5. Patients with central nervous system metastasis or \> grade 1 peripheral neuropathy;
6. Patients with severe myelosuppression at the time of screening;
7. Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
8. Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
9. Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
10. Patients with mental disorders;
11. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
12. Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.

Primary outcomes:
measure: pathologic complete response (pCR) rate
timeFrame: 21 weeks
Secondary outcomes:
measure: Total clinical response rate
timeFrame: 21 weeks
Other outcomes:
Locations:
Study officials:
References: