HER2+ Advanced Breast Cancer Patients Progressing on TKI TherapyNCT05560308
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
A study testing Trastuzumab Emtansine for Injection and Pyrotinib Maleate Tablets in people with HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy
- What is being tested?
- Trastuzumab Emtansine for Injection and Pyrotinib Maleate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 23 Aug 2025
- Phase
- Interventional
- 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 breast cancer patients aged ≥18 years and ≤75 years old
- HER2 positive (IHC3+, or IHC2+ and positive FISH test) confirmed by the center
- ECOG score 0-1
- Patients with advanced breast cancer who have progressed on lapatinib or pyrotinib
- There are measurable lesions
- Left ventricular ejection fraction (LVEF) ≥ 50%
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- 12-lead ECG: Fridericia-corrected QT interval (QTcF) in women < 470 ms;
- The function level of major organs must meet the following requirements: blood routine: ANC≥1.5×109/L; PLT≥90×109/L; Hb≥90g/L; blood biochemistry: TBIL≤2.5×ULN; ALT and AST≤2.5 ×ULN; BUN and Cr ≤ 1.5×ULN;
- For female subjects who are not menopausal or surgically sterilized, agree to abstain from sex or use effective contraceptive methods during the treatment period and for at least 2 months after the last dose in the study treatment;
- Voluntarily join the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Who cannot join
- Patients who have previously used ADCs to treat advanced breast cancer
- Symptomatic patients with brain metastases
- Control unstable pleural effusion and ascites patients
- Patients with previous or concurrent malignancies whose natural medical history or treatment may interfere with the safety or efficacy assessment of the study protocol are not eligible to participate in this trial, except for basal cell or squamous cell skin cancer, cervical cancer in situ, or bladder cancer , or the subject has lived free of disease (other cancers) for at least 5 years.
- Active infection requiring systemic treatment
- Gastrointestinal dysfunction or disease that may seriously affect the absorption of the study drug (such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) or severely impair the ability to swallow capsules/tablets
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- Known history of myelodysplastic syndrome or acute myeloid leukemia
- History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days
- Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months
- History of acute coronary syndrome (including myocardial infarction, unstable angina, coronary artery, arterial bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 6 years
- Symptomatic congestive heart failure (New York Heart Association III-IV) or cardiomyopathy with left ventricular ejection fraction (LVEF) <50%
- Clinically significant ventricular arrhythmia (sustained tachycardia/ventricular fibrillation) or high-grade AV block (eg, bifascicular block, Mobitz type II, and third-degree AV block), unless fitted pacemaker
- Any concurrent severe and/or uncontrolled medical conditions that, in the judgment of the investigator, would result in unacceptable safety risks, prohibit subjects from participating in clinical studies, or affect protocol compliance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.
- Being tested
- Trastuzumab Emtansine for Injection, Pyrotinib Maleate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Emtansine for InjectionDrug
3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle;
Pyrotinib Maleate TabletsDrug
The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle;
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets | Experimental | Trastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death. Receives: Drug: Trastuzumab Emtansine for Injection; Drug: Pyrotinib Maleate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(objective response rate)
rate of CR and PR in all subjects
Measured: Estimated 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion23 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2+ Advanced Breast Cancer Patients Progressing on TKI TherapyStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560308
- Sponsor's protocol ID
- BC- T-DM1
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 3 Oct 2022
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
- ClinicalTrials.gov ID
- NCT05560308
- Acronym / sponsor ID
- BC- T-DM1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 23 Aug 2025 (estimated)
- First posted
- 29 Sep 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.
This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets | Experimental | Drug: Trastuzumab Emtansine for Injection, Drug: Pyrotinib Maleate TabletsTrastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death. |
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 breast cancer patients aged ≥18 years and ≤75 years old
- HER2 positive (IHC3+, or IHC2+ and positive FISH test) confirmed by the center
- ECOG score 0-1
- Patients with advanced breast cancer who have progressed on lapatinib or pyrotinib
- There are measurable lesions
Key exclusion criteria (13 listed)
- Patients who have previously used ADCs to treat advanced breast cancer
- Symptomatic patients with brain metastases
- Control unstable pleural effusion and ascites patients
- Patients with previous or concurrent malignancies whose natural medical history or treatment may interfere with the safety or efficacy assessment of the study protocol are not eligible to participate in this trial, except for basal cell or squamous cell skin cancer, cervical cancer in situ, or bladder cancer , or the subject has lived free of disease (other cancers) for at least 5 years.
- Active infection requiring systemic treatment
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 |
|---|---|---|
| Trastuzumab Emtansine for Injection3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; | Drug | Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets |
| Pyrotinib Maleate TabletsThe initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; | Drug | Trastuzumab Emtansine for Injection；Pyrotinib Maleate Tablets |
Primary outcome
ORR(objective response rate)
Time frame: Estimated 24 months
rate of CR and PR in all subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Trastuzumab Emtansine for Injection and Pyrotinib Maleate Tablets in people with HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy, run by Tianjin Medical University Cancer Institute and Hospital.
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 13 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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Chunfang Hao, PhD (13602031629, haochf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(objective response rate) (time frame: Estimated 24 months). 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 3 Oct 2022.