Breast CancerPhase 1/2NCT04152057
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer
A Phase 1/2 study testing Pyrotinib Maleate Tablets, Albumin Paclitaxel and Trastuzumab in people with Breast Cancer and HER2 Positive, run by West China Hospital at 1 site in China.
Trial summary
This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, HER2 Positive, Combination Chemotherapy
- What is being tested?
- Pyrotinib Maleate Tablets, Albumin Paclitaxel and Trastuzumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2019to Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, and ≤ 70 years old .
- ECOG full body status 0-1 .
- According to the RECIST 1.1 standard, at least one measurable lesion exists.
- The pathological examination confirmed the positive expression of HER2, the clinical stage was stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) criteria] breast cancer patients .
- Note: HER2 expression positive refers to the pathological detection/review of primary or metastatic lesions performed by the pathology department of the Institute of Research and Development, at least once, at least 10% of tumor cells have immunohistochemical staining intensity of 3+ [staining intensity] Range 0 to 3] or positive by fluorescence in situ hybridization [FISH].
- The functional level of organs must meet the following requirements: ANC≥1.5×10E+9/L,PLT≥90×10E+9/L,Hb≥90 g/L,TBIL≤1.5×ULN,ALT 和 AST≤2×ULN,BUN 和 Cr≤ 1.5×ULN 且Creatinine clearance ≥50 mL/min（Cockcroft-Gault）.Echocardiography:LVEF≥50%,12-lead ECG:The QT interval (QTcF) corrected by the Fridericia method was < 450 ms for males and < 470 ms for females.
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- Patients with known hormone receptor status .
- In patients with a negative serum pregnancy test, patients with fertility potential must agree to use an effective non-hormonal contraceptive method during treatment and at least 6 months after the last use of the test drug.
- Volunteered to join the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.
Who cannot join
- Not selected as a subject in any of the following circumstances
- Patients with inflammatory breast cancer .
- Patients with metastatic breast cancer (stage IV) .
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting the administration and absorption of drugs .
- Patients who received radiotherapy, chemotherapy, surgery (large surgery for breast cancer) or molecular targeted therapy 4 weeks before randomization were randomized to receive endocrine therapy within 7 days prior to randomization.
- Participated in other drug clinical trials within 4 weeks before randomization .
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- The body has previously used or is using HER2-targeted monoclonal antibodies or tyrosine kinase inhibitor (including Trastuzumab,Pertuzumab,Lapatinib,Linatinib and Pyrotinib).
- Has had other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma.
- Also accept any other anti-tumor treatment .
- Known to have a history of allergies to the drug components of this regimen; history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation .
- Have had any heart disease, including: (1) angina; (2) drug-treated or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any subject judged Other heart diseases that are not suitable for this trial, etc.
- Female patients in pregnancy or lactation, female patients with fertility and positive pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period.
- According to the investigator's judgment, there are serious concomitant diseases that are harmful to the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, etc. that the drug cannot control).
- Have a clear history of neurological or mental disorders, including epilepsy or dementia.
- Accompanying CYP3A4 inhibitor or inducer .
- The investigator believes that the patient is not eligible for any other study in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Chengdu, Sichuan, China, 610041
Ting Luo, MD, +8618602866299, tina621@163.com
Ting Luo, MD, +8618980606230, tina621@163.com
About this study
Official title: A Single-arm, Exploratory Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Early or Locally Advanced Breast Cancer and Its Biomarkers
This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the treatment with pyrotinib.
Read the detailed description
At present, the treatment mode of breast cancer has gradually turned to the individualized comprehensive treatment mode combining systemic therapy and local therapy, and neoadjuvant therapy is widely used. Albumin-bound paclitaxel alters the excipients, reduces adverse reactions and greatly enhances efficacy, facilitating clinical applications. Studies have shown that in the use of neoadjuvant chemotherapy, drugs containing purple shirts and anthracyclines will be the drug of choice. The HER2/erbB2 molecule is an independent prognostic factor for breast cancer. About 20%-30% of adenocarcinoma patients have amplification/overexpression of HER2 gene. These patients are insensitive to conventional therapy and are more prone to recurrence and metastasis. Shorter survival and poorer prognosis. Current drugs targeting HER2 targets mainly include macromolecular monoclonal antibodies and their conjugates and small molecule tyrosine kinase inhibitors. Pyrotinib is an irreversible inhibitor of small targets (EGFR and HER2). Compared with trastuzumab, it has different sites of action, which may lead to synergy in the treatment of human Her2-positive breast cancer.
The excellent clinical efficacy of dual-targeted neoadjuvant therapy for Her2 positive breast cancer, the anti-tumor effect and good tolerance of pyrotinib, we intend to develop a pyrotinib combined with albumin paclitaxel and trastuzumab one-arm exploratory clinical study of neoadjuvant therapy for Her2-positive early or locally advanced breast cancer with the aim of assessing efficacy and safety, and exploring the efficacy of tumor-associated molecular markers such as RCB scores and TILs expression for pyrotinib treatment predicting effectiveness.
- Conditions
- Breast Cancer, HER2 Positive, Combination Chemotherapy
- Being tested
- Pyrotinib Maleate Tablets, Albumin Paclitaxel, Trastuzumab
- Keywords
- Pyrotinib Maleate Tablets, Trastuzumab, Albumin Paclitaxel, Early or Locally Advanced, neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib Maleate TabletsDrug
Also called Malaisuan Biluotini Pian, Ai Rui Ni
400mg/d,po qd,q3w, 4 cycles
Albumin PaclitaxelDrug
Also called Ai Yue
125mg/m2,ivggt,d1,q3w,4 cycles.
TrastuzumabDrug
Also called Qutuozhu DanKang, Herceptin
The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab | Experimental | Preoperative
-Drug: Pyrotinib Maleate Tablets combined with Albumin Paclitaxel and Trastuzumab.
Surgery:Subjects should be evaluated by tumor-enhanced MRI combined with mammary gland ultrasound during the preoperative neoadjuvant administration, and evaluated every 2 cycles. The subjects who were evaluated for CR and PR for the first time should be confirmed after at least 4 weeks. The confirmed tumor assessment cannot change the previously fixed examination time point.
Postoperative
* Drug: Epirubicin hydrochloride combined with Cyclophosphamide
* At the same time, according to the recommendation of the clinician, choose whether to accept the same anti-HER2 treatment plan before surgery. For patients with tumors positive for estrogen receptor (ER) and/or progesterone receptor (PR), endocrine therapy should be given at the end of adjuvant chemotherapy, and if there is clinical indication at the end of adjuvant chemotherapy, radiotherapy should be given. Receives: Drug: Pyrotinib Maleate Tablets; Drug: Albumin Paclitaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic Complete Response(pCR)（ypT0/is N0）
Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.
Measured: Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) .
Secondary outcomes (4)
Overall Response Rate (ORR)
The proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.
Measured: up to 2 years
Disease Control Rate (DCR)
The proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST1.1 by the investigator.
Measured: up to 2 years
Residual Cancer Burden (RCB)
The RCB category (RCB-0, RCB-I, RCB-II, or RCB-III) was defined according to the M.D. Anderson Cancer Center standard, and the RCB score was associated with the patient's prognosis.
Measured: up to 2 years
Tumor Infiltrating Lymphocytes (TILS)
This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub types.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shuangyue Liu, West China Hospital
- Investigators
- Ting Luo, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152057
- Sponsor's protocol ID
- BLTN-NeoBC1115
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhong X, He P, Chen J, Yan X, Wei B, Zhang Z, Bu H, Li J, Tian T, Lv Q, Wang X, Li H, Wang J, Huang J, Suo J, Liu X, Zheng H, Luo T. Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel for HER2-positive early or locally advanced breast cancer: an exploratory phase II trial. Gland Surg. 2022 Jan;11(1):216-225. doi: 10.21037/gs-21-911.
PubMed 35242683
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Early or Locally Advanced Breast Cancer and Its Biomarkers
- ClinicalTrials.gov ID
- NCT04152057
- Acronym / sponsor ID
- BLTN-NeoBC1115
- Conditions
- Breast Cancer, HER2 Positive, Combination Chemotherapy
- Keywords
- Pyrotinib Maleate Tablets, Trastuzumab, Albumin Paclitaxel, Early or Locally Advanced, neoadjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Nov 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the treatment with pyrotinib.
Detailed description
At present, the treatment mode of breast cancer has gradually turned to the individualized comprehensive treatment mode combining systemic therapy and local therapy, and neoadjuvant therapy is widely used. Albumin-bound paclitaxel alters the excipients, reduces adverse reactions and greatly enhances efficacy, facilitating clinical applications. Studies have shown that in the use of neoadjuvant chemotherapy, drugs containing purple shirts and anthracyclines will be the drug of choice. The HER2/erbB2 molecule is an independent prognostic factor for breast cancer. About 20%-30% of adenocarcinoma patients have amplification/overexpression of HER2 gene. These patients are insensitive to conventional therapy and are more prone to recurrence and metastasis. Shorter survival and poorer prognosis. Current drugs targeting HER2 targets mainly include macromolecular monoclonal antibodies and their conjugates and small molecule tyrosine kinase inhibitors. Pyrotinib is an irreversible inhibitor of small targets (EGFR and HER2). Compared with trastuzumab, it has different sites of action, which may lead to synergy in the treatment of human Her2-positive breast cancer.
The excellent clinical efficacy of dual-targeted neoadjuvant therapy for Her2 positive breast cancer, the anti-tumor effect and good tolerance of pyrotinib, we intend to develop a pyrotinib combined with albumin paclitaxel and trastuzumab one-arm exploratory clinical study of neoadjuvant therapy for Her2-positive early or locally advanced breast cancer with the aim of assessing efficacy and safety, and exploring the efficacy of tumor-associated molecular markers such as RCB scores and TILs expression for pyrotinib treatment predicting effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab | Experimental | Drug: Pyrotinib Maleate Tablets, Drug: Albumin Paclitaxel, Drug: TrastuzumabPreoperative -Drug: Pyrotinib Maleate Tablets combined with Albumin Paclitaxel and Trastuzumab. Surgery:Subjects should be evaluated by tumor-enhanced MRI combined with mammary gland ultrasound during the preoperative neoadjuvant administration, and evaluated every 2 cycles. The subjects who were evaluated for CR and PR for the first time should be confirmed after at least 4 weeks. The confirmed tumor assessment cannot change the previously fixed examination time point. Postoperative * Drug: Epirubicin hydrochloride combined with Cyclophosphamide * At the same time, according to the recommendation of the clinician, choose whether to accept the same anti-HER2 treatment plan before surgery. For patients with tumors positive for estrogen receptor (ER) and/or progesterone receptor (PR), endocrine therapy should be given at the end of adjuvant chemotherapy, and if there is clinical indication at the end of adjuvant chemotherapy, radiotherapy should be given. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old, and ≤ 70 years old .
- ECOG full body status 0-1 .
- According to the RECIST 1.1 standard, at least one measurable lesion exists.
- The pathological examination confirmed the positive expression of HER2, the clinical stage was stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) criteria] breast cancer patients .
- Note: HER2 expression positive refers to the pathological detection/review of primary or metastatic lesions performed by the pathology department of the Institute of Research and Development, at least once, at least 10% of tumor cells have immunohistochemical staining intensity of 3+ [staining intensity] Range 0 to 3] or positive by fluorescence in situ hybridization [FISH].
Key exclusion criteria (16 listed)
- Not selected as a subject in any of the following circumstances
- Patients with inflammatory breast cancer .
- Patients with metastatic breast cancer (stage IV) .
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting the administration and absorption of drugs .
- Patients who received radiotherapy, chemotherapy, surgery (large surgery for breast cancer) or molecular targeted therapy 4 weeks before randomization were randomized to receive endocrine therapy within 7 days prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyrotinib Maleate TabletsAlso: Malaisuan Biluotini Pian, Ai Rui Ni400mg/d,po qd,q3w, 4 cycles | Drug | Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab |
| Albumin PaclitaxelAlso: Ai Yue125mg/m2,ivggt,d1,q3w,4 cycles. | Drug | Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab |
| TrastuzumabAlso: Qutuozhu DanKang, HerceptinThe first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles. | Drug | Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab |
Primary outcome
pathologic Complete Response(pCR)（ypT0/is N0）
Time frame: Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) .
Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Residual Cancer Burden (RCB)
Time frame: up to 2 years
Tumor Infiltrating Lymphocytes (TILS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 35242683Zhong X, He P, Chen J, Yan X, Wei B, Zhang Z, Bu H, Li J, Tian T, Lv Q, Wang X, Li H, Wang J, Huang J, Suo J, Liu X, Zheng H, Luo T. Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel for HER2-positive early or locally advanced breast cancer: an exploratory phase II trial. Gland Surg. 2022 Jan;11(1):216-225. doi: 10.21037/gs-21-911.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Luo, MD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pyrotinib Maleate Tablets, Albumin Paclitaxel and Trastuzumab in people with Breast Cancer and HER2 Positive, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Luo, MD (+8618602866299, tina621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic Complete Response(pCR)（ypT0/is N0） (time frame: Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04152057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.