Pyrotinib Trastuzumab Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2027
  • participants needed
    216
  • sponsor
    Shanghai Jiao Tong University School of Medicine
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Updated on 19 February 2024
See if I qualify
cancer
estrogen
breast cancer
paclitaxel
breast carcinoma
progesterone
breast cancer stage
estrogen receptor
invasive breast cancer
immunohistochemistry
trastuzumab
progesterone receptor
carcinoma
primary tumor
pertuzumab
adjuvant therapy
breast cancer staging
her2 positive breast cancer
pyrotinib
her2 gene amplification
gene amplification
her2-positive breast cancer
HER2
her2+ breast cancer
emtansine
erbb2 gene amplification
her2 positive breast carcinoma

Summary

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

Description

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel or 4 cycles of trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive adjuvant chemotherapy and targeted therapy according to pathologic response and physician's choice.

Details
Condition Breast Cancer Invasive
Age 18years - 75years
Treatment Surgery, nab-paclitaxel, Trastuzumab, Pyrotinib, Pertuzumab, EC chemotherapy, Physician's choice, T-DM1
Clinical Study IdentifierNCT04398914
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 II-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
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, ,Stage I uterine cancer or thyroid papillary microcarcinoma
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
Positive serum or urine pregnancy test or above mentioned tests cannot be achieved for women with fertility
Clear my responses
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cancer
estrogen
breast cancer
paclitaxel
breast carcinoma
progesterone
breast cancer stage
estrogen receptor
invasive breast cancer
immunohistochemistry
trastuzumab
progesterone receptor
carcinoma
primary tumor
pertuzumab
adjuvant therapy
breast cancer staging
her2 positive breast cancer
pyrotinib
her2 gene amplification
gene amplification
her2-positive breast cancer
HER2
her2+ breast cancer
emtansine
erbb2 gene amplification
her2 positive breast carcinoma

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