Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

A Randomized, Open-label, Multicenter Study Comparing Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Adjuvant Therapy
• Intervention / Treatment: Drug: Pyrotinib+Trastuzumab+Capecitabine; Drug: Trastuzumab+Pertuzumab/Trastuzumab

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Silu Wang; Phone Number: 18559171530; Email: wangsiluaaron@163.com
• Study Contact Backup: Name: Chuan Wang; Phone Number: 13515020716; Email: chuanwang68@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Silu Wang; Phone Number: 18559171530; Email: wangsiluaaron@163.com
      • Contact: Chuan Wang; Phone Number: 13515020716; Email: chuanwang68@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer
• ECOG score 0 ~ 1
• Breast cancer meets the following criteria: 1）Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods：cT1-4/N0-3/M0. 2）Pathologically confirmed HER2-expressing positive breast cancer, defined as > 10% immunoreactive cells with immunohistochemical (IHC) score of 3 + or in situ hybridization (ISH) results of HER2 gene amplification. 3)Known hormone receptor status (ER and PgR). 4)Neoadjuvant therapy (including: at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy)
• Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion > 2 cm or axillary lymph node positive with macrometastasis assessed by central laboratory)
• No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation
• Required laboratory values including following parameters:

ANC: ≥ 1.5 x 109/L Platelet count: ≥ 90 x 109/L Hemoglobin: ≥ 9.0 g/dL Total bilirubin: ≤ 1.5 x upper limit of normal, ULN ALT and AST: ≤ 1.5 x ULN BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 55% QTcF: < 470 ms

Exclusion Criteria:

• 1) Stage IV (metastatic) breast cancer;
• 2) inflammatory breast cancer;
• 3) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
• 4) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment);
• 5) Receiving any anti-tumor therapy within 28 days before enrollment;
• 6) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
• 7) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors;
• 8) Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240 mg/m2, epirubicin > 480 mg/m2;
• 9) Receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Pyrotinib: 400 mg/day (once daily, orally at the same time every day), every 3 weeks for one year Capecitabine: 1000 mg/m2 orally twice daily every 3 weeks for 6 cycles Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase)	Drug: Pyrotinib+Trastuzumab+Capecitabine; Patients in the experimental arm will receive trastuzumab + pyrotinib + capecitabine
Active Comparator: B; Patients in the control group will continue neoadjuvant targeted therapy, trastuzumab or trastuzumab in combination with pertuzumab. In case of neoadjuvant trastuzumab monotherapy, trastuzumab combined with pertuzumab targeted therapy is allowed in the adjuvant phase.	Drug: Trastuzumab+Pertuzumab/Trastuzumab; Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase) Pertuzumab: 840 mg loading dose followed by 420 mg fixed dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iDFS	3-year invasive disease-free survival (iDFS) rate	3 years

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab; Capecitabine; Pertuzumab
• Other Study ID Numbers: MA-BC-II-025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No