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

Shanghai Jiao Tong University School of Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer Invasive

Treatments: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Physician's choice; Drug: T-DM1; Drug: EC chemotherapy; Drug: Pyrotinib; Drug: Nab-paclitaxel; Procedure: Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04398914

RJBC2001

Details and patient eligibility

About

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.

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 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.

Enrollment: 216 estimated 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Pyrotinib, trastuzumab, pertuzmab and paclitaxel

Experimental group

Description:

Prior to surgery: pyrotinib, trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery： * if non-tpCR：chemotherapy with epirubicin and cyclophosphamide (EC), followed with pertuzumab and trastuzumab up to 1 year total; or T-DM1 for 14 cycles. * if tpCR: chemotherapy 0-4 cycles according to physician's choice, followed with pertuzumab and trastuzumab up to 1 year total.

Treatment:

Drug: T-DM1

Drug: Trastuzumab

Drug: Pertuzumab

Drug: Pyrotinib

Procedure: Surgery

Drug: Nab-paclitaxel

Drug: EC chemotherapy

Drug: Physician's choice

Trastuzumab, pertuzmab and paclitaxel

Active Comparator group

Description:

Prior to surgery: trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery： * if non-tpCR：chemotherapy with epirubicin and cyclophosphamide (EC), followed with pertuzumab and trastuzumab up to 1 year total; or T-DM1 for 14 cycles. * if tpCR: chemotherapy 0-4 cycles according to physician's choice; followed with pertuzumab and trastuzumab up to 1 year total.

Treatment:

Drug: T-DM1

Drug: Trastuzumab

Drug: Pertuzumab

Procedure: Surgery

Drug: Nab-paclitaxel

Drug: EC chemotherapy

Drug: Physician's choice