A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab,Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Newly treated female patients aged ≥18 years and ≤75 years;

• ECOG score 0\

∙ 1;

• Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;

• Hormone receptor status (ER and PgR) is known, where ER≥10%

• Normal function of major organs:

‣ The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L

⁃ Biochemical examination should meet the following standards: TBIL≤ the upper limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula);

⁃ Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%)

⁃ Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms;

• For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment;

• Volunteer to join the study and sign the informed consent.

Locations
Other Locations
China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
WuhanHU
RECRUITING
Wuhan
Contact Information
Primary
Yao Jing
jeaneyph@163.com
13971139665
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2028-05-11
Participants
Target number of participants: 62
Treatments
Experimental: pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel
Pyrotinib tablets: 320mg qd, 21 days for 1 cycle, continuous administration of 6 cycles.~Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles.~Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given.~Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov