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

Shanghai Jiao Tong University School of Medicine

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab; Drug: nab-Paclitaxel; Procedure: Surgery; Drug: Pyrotinib; Drug: EC chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04066790

RJBC1901

Details and patient eligibility

About

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.

Full 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 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 nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Pyrotinib in combination with nab-paclitaxel

Experimental group

Description:

Prior to surgery: pyrotinib and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.

Treatment:

Procedure: Surgery

Drug: nab-Paclitaxel

Drug: EC chemotherapy

Drug: Trastuzumab

Drug: Pyrotinib

Trastuzumab in combination with nab-paclitaxel

Active Comparator group

Description:

Prior to surgery: trastuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.

Treatment:

Procedure: Surgery

Drug: nab-Paclitaxel

Drug: EC chemotherapy

Drug: Trastuzumab