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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female patients aged ≥18 years;

• unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;

• The tumor is \>2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;

• 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);

• 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);

• patients who need neoadjuvant chemotherapy as judged by the investigator;

• ECOG physical fitness score of 0-1;

• The patient has not received any treatment for breast cancer before enrollment;

• Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%;

⁃ 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 ;

⁃ Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;

⁃ Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;

⁃ 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).

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Yiding CHEN
ydchen@zju.edu.cn
13605719519
Backup
Huihui CHEN
huihuicyj@zju.edu.cn
571-87784527
Time Frame
Start Date: 2022-07-10
Estimated Completion Date: 2027-12-20
Participants
Target number of participants: 1576
Treatments
Active_comparator: TCbHP
HER2-positive breast cancer
Experimental: nPCbHP
HER2-positive breast cancer
Active_comparator: EC-T
Luminal breast cancer (HER2-, LN+), and triple negative breast cancer
Experimental: ddEC-wnP
Luminal breast cancer (HER2-, LN+), and triple negative breast cancer
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov