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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

Sponsor
Fujian Medical University Union Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05292742
Collaborator
(none)
206
Enrollment
1
Location
2
Arms
78
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
206 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 2, 2021
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. iDFS [3 years]

    3-year invasive disease-free survival (iDFS) rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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;
    1. inflammatory breast cancer;
    1. Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
    1. Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment);
    1. Receiving any anti-tumor therapy within 28 days before enrollment;
    1. Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
    1. Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors;
    1. Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240 mg/m2, epirubicin > 480 mg/m2;
    1. Receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Medical University Union Hospital Fuzhou Fujian China 350001

Sponsors and Collaborators

  • Fujian Medical University Union Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier:
NCT05292742
Other Study ID Numbers:
  • MA-BC-II-025
First Posted:
Mar 23, 2022
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Capecitabine
Trastuzumab
Pertuzumab

Study Results

No Results Posted as of Mar 23, 2022