Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer

NCT ID: NCT04659499

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2025-06-30

Brief Summary

This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.

Conditions

Early Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel in combination with pyrotinib treatment group

Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year

Group Type: EXPERIMENTAL

Nab-paclitaxel in combination with pyrotinib

Intervention Type: DRUG

Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year

Interventions

Nab-paclitaxel in combination with pyrotinib

Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
• The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
• Tumor should has known ER/PR hormone receptor status.
• All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to 1.
• Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
• left ventricular ejection fraction (LVEF) ≥ 50% and Electrocardiogram Fridericia-corrected QT interval (QTcF) ≤ 480 ms.
• Provide written informed consent.

Exclusion Criteria

• Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
• Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
• Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
• Inability to swallow, chronic diarrhea, or intestinal obstruction.
• Known to be allergic to the drug components.
• Have a history of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B or other immunodeficiency diseases.
• Have a history of organ transplantation.
• Pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive.
• Any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure.
• Any other concomitant diseases assessed by investigator as unsuitable for study.
• Previous history of definite neurological or psychiatric disorders.
• Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qiang Sun, MD

Role: CONTACT

Phone: +861069152700

Email: sunqiangpumc@sina.com

Changjun Wang, MD

Role: CONTACT

Phone: +861069158721

Email: wangchangjun@pumch.cn

References

Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Rationale and design of a phase II trial of pyrotinib in combination with nab-paclitaxel as adjuvant therapy for N0/N1mi, HER2 + early breast cancer (PHAEDRA). BMC Cancer. 2022 Mar 14;22(1):269. doi: 10.1186/s12885-022-09346-1.

Reference Type: DERIVED

PMID: 35287613 (View on PubMed)

Other Identifiers

MA-BC-II-007

Identifier Type: -

Identifier Source: org_study_id