HER2-positive Breast CancerPhase 2NCT05429294
Novel Double Target Therapy Combined With Chemotherapy in First-line Treatment of HER2+ Breast Cancer, MA-BC-II-038
A Phase 2 study testing Pyrotinib in people with HER2-positive Breast Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of pyrotinib combined with trastuzumab and albumin paclitaxel in first-line treatment of HER2-positive advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Oct 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 aged ≥18 years and ≤75 years.
- Pathologically confirmed diagnosis of Her2-positive advanced or metastatic breast cancer.
- ECOG 0 ~ 1.
- At least one measurable lesion according to RECIST 1.1.
- No prior anti-HER2 therapy and chemotherapy for MBC, and other anti-tumor therapy that the investigator considers to be excluded, and are permitted to undergo local therapy for local symptoms, such as radiotherapy for relief of bone pain.
- Patients with a disease-free interval of ≥12 months between the end of systemic therapy (except endocrine therapy) and tumor recurrence/metastasis after prior adjuvant/neoadjuvant systemic therapy are permitted.
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- Life expectancy is not less than 12 weeks.
- hormone receptor status is known.
- Normal function of important organs, including heart, liver, lung, kidney and bone marrow.
- Volunteered to participate in the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.
Who cannot join
- Patients with central nervous system metastasis.
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption.
- Patients who had received radiotherapy, chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks prior to enrollment.
- Those who had received endocrine therapy within 2 weeks before enrollment.
- Tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib, pyrolitinib, etc.) have been used or are currently being used.
- Have used or are using T-DM1 before.
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- Other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
- The researchers judged those who were not eligible for systemic chemotherapy.
- Patients had undergone major surgical procedures or significant trauma in the 4 weeks prior to enrollment, or were expected to undergo major surgical treatment.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B, hepatitis C (positive for hepatitis C antibodies and hcV-RNA higher than the detection limit for analytical methods) or co-infection with hepatitis B and C.
- History of any heart disease including :(1) angina pectoris; (2) arrhythmias requiring drug treatment or of clinical significance; (3) myocardial infarction; (4) heart failure; (5) Any other heart disease deemed unsuitable for the study by the investigator.
- Pregnant, lactating women, fertile women who tested positive for baseline pregnancy, or women of childbearing age who were unwilling to use effective contraception during the entire trial period.
- According to the judgment of the investigator, there are serious concomitant diseases (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.) that seriously endanger patients' safety or affect patients' ability to complete the study.
- Known allergy to pyrotinib, trastuzumab, albumin paclitaxel or any excipient.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Concomitant use of CYP3A4 inhibitors or inducers or ongoing use of drugs that prolong QT interval.
- Known history of psychotropic substance abuse or drug abuse.
- Other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, and any other conditions that the investigator considers inappropriate for study participation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jin Yang
Xi'an, Shaanxi, 710061
Jin Yang, +862985323473, 792171443@qq.com
About this study
Official title: Pyrotinib Combined With Trastuzumab and Albumin Paclitaxel in First-line Treatment of HER2-positive Advanced or Metastatic Breast Cancer, a Prospective, Single-arm, Multicenter, Phase II Study
The purpose of this study was to evaluate the efficacy and safety of pyrotinib combined with trastuzumab and albumin paclitaxel in first-line treatment of HER2-positive advanced or metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Also called Trastuzumab, Albumin paclitaxel
Patients with HER2-positive advanced/metastatic breast cancer are treated with pyrotinib combined with trastuzumab and albumin paclitaxel in the first-line setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pyrotinib combined with trastuzumab and albumin paclitaxel Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The length of the time during and after the treatment until disease progressed
Measured: during the procedure
Secondary outcomes (2)
ORR
The percent of patients who have CR or PR among all the patients enrolled
Measured: during the procedure
OS
The the length of time from the enrollment to death
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jun 2022
- Primary completion31 May 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 209 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Jin Yang, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429294
- Sponsor's protocol ID
- X-XJTU1AFLSY-93
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib Combined With Trastuzumab and Albumin Paclitaxel in First-line Treatment of HER2-positive Advanced or Metastatic Breast Cancer, a Prospective, Single-arm, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT05429294
- Acronym / sponsor ID
- X-XJTU1AFLSY-93
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Jun 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.
The purpose of this study was to evaluate the efficacy and safety of pyrotinib combined with trastuzumab and albumin paclitaxel in first-line treatment of HER2-positive advanced or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: PyrotinibPyrotinib combined with trastuzumab and albumin paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged ≥18 years and ≤75 years.
- Pathologically confirmed diagnosis of Her2-positive advanced or metastatic breast cancer.
- ECOG 0 ~ 1.
- At least one measurable lesion according to RECIST 1.1.
- No prior anti-HER2 therapy and chemotherapy for MBC, and other anti-tumor therapy that the investigator considers to be excluded, and are permitted to undergo local therapy for local symptoms, such as radiotherapy for relief of bone pain.
Key exclusion criteria (18 listed)
- Patients with central nervous system metastasis.
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption.
- Patients who had received radiotherapy, chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks prior to enrollment.
- Those who had received endocrine therapy within 2 weeks before enrollment.
- Tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib, pyrolitinib, etc.) have been used or are currently being used.
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 |
|---|---|---|
| PyrotinibAlso: Trastuzumab, Albumin paclitaxelPatients with HER2-positive advanced/metastatic breast cancer are treated with pyrotinib combined with trastuzumab and albumin paclitaxel in the first-line setting. | Drug | Intervention |
Primary outcome
PFS
Time frame: during the procedure
The length of the time during and after the treatment until disease progressed
2 secondary outcomes
ORR
Time frame: during the procedure
OS
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- 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.
Jin Yang principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 in people with HER2-positive Breast Cancer, run by First Affiliated Hospital Xi'an Jiaotong 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 10 inclusion and 18 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 23 Jun 2022. 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 Yang (+862985323473, 792171443@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: during the procedure). 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 23 Jun 2022.