Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

• Status: Terminated
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• With signed consent

• Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique

• Breast cancer stage at presentation: stage I-III

• HER2-positive breast cancer defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization

• Known hormone receptor status (estrogen receptor and/or progesterone receptor)

• Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1

• Baseline left ventricular ejection fracture >= 50% measured by echocardiography

• Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male

• Negative serum pregnancy test for women with fertility

• Willing to obey the study protocol

Exclusion Criteria:

• Stage IV disease

• Previous anti-cancer therapy or radiotherapy for any malignancy

• History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer

• Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy

• Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered

• Serious cardiac illness or medical condition

• Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness

• Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization

• Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol

• Not able to swallow the drug

• Pregnant or lactating