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ACTIVE_NOT_RECRUITINGPHASE2

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

A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib Plus Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer

NCT04398914•Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

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 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.

Eligibility

Age

18 - 75 years

Sex

ALL

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
+2 more criteria

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 30, 2020

Primary Completion Date

December 30, 2022

Completion Date

December 30, 2027

Last Updated

March 31, 2022

Enrollment

216

ESTIMATED participants

Conditions

Breast Cancer Invasive

Interventions

Pyrotinib

DRUG

Trastuzumab

DRUG

Pertuzumab

DRUG

Nab-paclitaxel

DRUG

EC chemotherapy

DRUG

Physician's choice

DRUG

T-DM1

DRUG

Surgery

PROCEDURE

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

NCT07188246

Breast CancerBreast Cancer Stage II+3 more

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RECRUITINGNA

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Breast Cancer InvasiveNode Positive Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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