Status:
TERMINATED
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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-po...
Detailed Description
The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04066790
Start Date
September 9 2019
End Date
April 30 2020
Last Update
May 19 2020
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025