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

NCT04066790 | Terminated Phase 2

• 1 other identifier: RJBC1901
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

HER2-positive; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Total Pathologic Complete Response (tpCR)

  tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer \[AJCC\] staging system).The duration of one treatment cycle is 21 days.

  Cycle 4 . The duration of one treatment cycle is 21 days.

Secondary Outcomes (5)

• Percentage of Participants With Breast Pathologic Complete Response (bpCR)

  Cycle 4 . The duration of one treatment cycle is 21 days.

• Clinical response

  Cycle 4 . The duration of one treatment cycle is 21 days.

• Event-free survival (EFS)

  From Baseline to EFS event or date last known to be alive and event-free (up to 5 years)

• Disease-free survival (DFS)

  From surgery to DFS event or date last known to be alive and event-free (up to 5 years)

• Overall survival (OS)

  From Baseline to OS event or date last known to be alive (up to 5 years)

Other Outcomes (1)

• Percentage of Participants With At Least One Adverse Event During Treatment Period

  From randomization to 30 days after completion of study treatment

Study Arms (2)

Pyrotinib in combination with nab-paclitaxel

EXPERIMENTAL

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.

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

Trastuzumab in combination with nab-paclitaxel

ACTIVE COMPARATOR

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.

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

Interventions

Pyrotinib DRUG

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

Pyrotinib in combination with nab-paclitaxel

nab-Paclitaxel DRUG

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

Pyrotinib in combination with nab-paclitaxel; Trastuzumab in combination with nab-paclitaxel

Trastuzumab DRUG

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 for Cycle 9, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab

Pyrotinib in combination with nab-paclitaxel; Trastuzumab in combination with nab-paclitaxel

EC chemotherapy DRUG

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

Pyrotinib in combination with nab-paclitaxel; Trastuzumab in combination with nab-paclitaxel

Surgery PROCEDURE

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

Pyrotinib in combination with nab-paclitaxel; Trastuzumab in combination with nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; 130-nm albumin-bound paclitaxel; Trastuzumab; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kunwei Shen, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: September 9, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)