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NCT04398914

PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2020-05-30

Completion Date

2027-12-30

Last Updated

2022-03-31

Healthy Volunteers

Conditions

Breast Cancer Invasive

Interventions

DRUG

Pyrotinib

Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.

DRUG

Trastuzumab

Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab

DRUG

Pertuzumab

Pertuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. Adjuvant treatment: 840 mg loading dose, followed by 420mg for remaining cycles till completion of 1 year pertuzumab

DRUG

Nab-paclitaxel

Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.

DRUG

EC chemotherapy

Epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks for 4 cycles (Cycles 5-8)

DRUG

Physician's choice

Physician decided chemotherapy for 0-4 cycles.

DRUG

T-DM1

T-DM1 IV infusion in 3-week cycles. 3.6 mg/kg by intravenous (IV) infusion every 3 weeks for 14 cycles

PROCEDURE

Surgery

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

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

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)