Overview

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