- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066790
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
May 16, 2020 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine
A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pyrotinib in combination with nab-paclitaxel
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.
|
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.
Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.
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
epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks 4 cycles (Cycles 5-8)
|
Active Comparator: Trastuzumab in combination with nab-paclitaxel
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.
|
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.
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
epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks 4 cycles (Cycles 5-8)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Total Pathologic Complete Response (tpCR)
Time Frame: Cycle 4 . The duration of one treatment cycle is 21 days.
|
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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival (EFS)
Time Frame: From Baseline to EFS event or date last known to be alive and event-free (up to 5 years)
|
EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause.
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From Baseline to EFS event or date last known to be alive and event-free (up to 5 years)
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Disease-free survival (DFS)
Time Frame: From surgery to DFS event or date last known to be alive and event-free (up to 5 years)
|
DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery.
Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause.
|
From surgery to DFS event or date last known to be alive and event-free (up to 5 years)
|
Overall survival (OS)
Time Frame: From Baseline to OS event or date last known to be alive (up to 5 years)
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OS was defined as the time from randomization to death from any cause.
|
From Baseline to OS event or date last known to be alive (up to 5 years)
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Percentage of Participants With Breast Pathologic Complete Response (bpCR)
Time Frame: Cycle 4 . The duration of one treatment cycle is 21 days.
|
bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).The duration of one treatment cycle is 21 days.
|
Cycle 4 . The duration of one treatment cycle is 21 days.
|
Clinical response
Time Frame: Cycle 4 . The duration of one treatment cycle is 21 days.
|
Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
The duration of one treatment cycle is 21 days.
|
Cycle 4 . The duration of one treatment cycle is 21 days.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With At Least One Adverse Event During Treatment Period
Time Frame: From randomization to 30 days after completion of study treatment
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The percentage of participants who experienced at least one adverse event during the neoadjuvant period, surgery, adjuvant treatment period.
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From randomization to 30 days after completion of study treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kunwei Shen, MD, Ruijin Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2019
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 26, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 16, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJBC1901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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