Breast CancerPhase 2NCT05659056
Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer
A Phase 2 study testing Pyrotinib, trastuzumab, paclitaxel-albumin in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib, trastuzumab, paclitaxel-albumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2022to Jul 2024
- Phase
- Phase 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients, 18 years ≤ age ≤ 75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
- Primary breast cancer;
- Known hormone receptor status.
- The organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
Who cannot join
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Wenbin Zhou, Professor, 025-68308162, zhouwenbin@njmu.edu.cn
About this study
Official title: Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib, trastuzumab, paclitaxel-albumin
- Keywords
- HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib, trastuzumab, paclitaxel-albuminDrug
pyrotinib: 400mg orally daily; trastuzumab: 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; paclitaxel-albumin: 260mg/m2, every 3 week, a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib, trastuzumab, paclitaxel-albumin | Experimental | Not described Receives: Drug: Pyrotinib, trastuzumab, paclitaxel-albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
pCR
Measured: Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)
Secondary outcomes (3)
Event-free survival
EFS
Measured: Following surgery until year 2
Objective Response Rate
ORR
Measured: Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days)
minimal residual lesions
MRD
Measured: Following surgery until year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start29 Nov 2022
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shui Wang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659056
- Sponsor's protocol ID
- NJMU-BC01
- Status last verified
- Apr 2024
- First submitted
- 2 Dec 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
- ClinicalTrials.gov ID
- NCT05659056
- Acronym / sponsor ID
- NJMU-BC01
- Conditions
- Breast Cancer
- Keywords
- HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Dec 2022 (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.
Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib, trastuzumab, paclitaxel-albumin | Experimental | Drug: Pyrotinib, trastuzumab, paclitaxel-albumin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female patients, 18 years ≤ age ≤ 75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
- Primary breast cancer;
Key exclusion criteria (5 listed)
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
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, trastuzumab, paclitaxel-albuminpyrotinib: 400mg orally daily; trastuzumab: 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; paclitaxel-albumin: 260mg/m2, every 3 week, a total of 6 cycles | Drug | Pyrotinib, trastuzumab, paclitaxel-albumin |
Primary outcome
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
Time frame: Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)
pCR
3 secondary outcomes
Event-free survival
Time frame: Following surgery until year 2
Objective Response Rate
Time frame: Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days)
minimal residual lesions
Time frame: Following surgery until year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib, trastuzumab, paclitaxel-albumin in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 8 inclusion and 5 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 16 Apr 2024. 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 phase mean?
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 Wenbin Zhou, Professor (025-68308162, Zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators (time frame: Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.