Metastatic Breast Cancer in the BrainPhase 2NCT06475443
Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs
A Phase 2 study testing pyrotinib plus capecitabine in people with Metastatic Breast Cancer in the Brain, run by Henan Cancer Hospital.
Trial summary
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer in the Brain
- What is being tested?
- pyrotinib plus capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- Pathologically confirmed HER2-positive invasive breast cancer with metastatic disease; patients with no pathological or cytologically confirmed metastatic disease should obtain clear evidence of metastasis through physical examination or radiological examination; Note: Positive HER2 -positive refers in the pathological examination/rechecking of primary lesions or metastatic lesions performed by the Research site's Pathology Laboratory, at least once the tumour cells defined as 3+ staining by immunohistochemistry, or fluorescence in situ hybridization (FISH) confirmed positive;
- Fam-trastuzumab deruxtecan-nxki or A1811 had failed treatment for active brain metastasis and had received no local radiotherapy previously. Patients with new lesions in the brain after craniotomy are allowed to be included, provided that radiotherapy is not performed after surgery;
- Enhanced MRI confirmed brain metastasis. According to RANO criteria, there is at least one measurable brain lesion, and the measurability of extracranial lesions is not required;
- Previous treatment:Capecitabine is not allowed, except for patients without progression or intolerance during use and no relapse at least 6 months (as neoadjuvant /adjuvant therapy) after discontinuation of a capecitabine-containing treatment. Pyrotinib is not allowed, except for patients without progression or intolerance during use and no relapse at least 6 months (as neoadjuvant /adjuvant therapy) after discontinuation of a pyrotinib-containing treatment ; Patients who have not previously used pyrotinib , but have used pyrotinib in the neoadjuvant / adjuvant phase, have not proven disease progression or intolerance during use, and have relapsed 6 months after the last dose are allowed to be enrolled; Concurrent use of bisphosphonates, mannitol and glucocorticoids is allowed, provided that the dosage (<2 mg dexamethasone [or equivalent])
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- Expected survival period of 3 months;
- Patients must have adequate organ function, criteria as follows: Blood routine test (no blood transfusion within 14 days, no correction of Granulocyte colony-stimulating factor(G-CSF) and other hematopoietic stimulating factors): Absolute Neutrophil Count (ANC) 1.5X10^9 / L; PLT 75X10^9 / L; Hemoglobin（Hb） 90g / L; Blood chemistry test:total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); Alanine transaminase(ALT) and Aspartate transaminase(AST) ≤3 times ULN; For patients with liver metastases, ALT and AST ≤5 times ULN(Upper Limit of Normal); Blood urea nitrogen(BUN) and creatinine(Cr) ≤1 times ULN and creatinine clearance ≥ 50 mL/min (CockcroftGault formula);Ultrasonic cardiogram: left ventricular ejection fraction (LVEF) ≥50%; Electrocardiograph (ECG): The QT interval corrected by Fridericia's formula (QTcF)is less than 450 ms for males and less than 470 ms for females.
- Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.
Who cannot join
- Previous treatment for active brain metastases included other anti-tumor therapy except for T-DXd or A1811;
- Active brain metastases requiring radiotherapy; Patients with leptomeningeal metastasis (diagnosed by imaging/positive cerebrospinal fluid cytology) or a clear indication of clinically significant leptomeningeal involvement;
- Central Nervous System(CNS) complications that require urgent neurosurgical intervention (e.g. resection, shunt placement). Patients with poorly response brain metastases after dehydration treatment and glucocorticoid treatment, such as uncontrollable increase in intracranial pressure, jet vomiting, mental disorders, epilepsy, cognitive impairment, etc;
- Third space fluid that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites);
- Patients who have received anti-tumor radiotherapy or surgery within 2 weeks before enrollment (minor surgery, such as tumor biopsy, thoracentesis,intravenous catheterization or the like are allowed); patients who have received endocrine therapy within 1 week before enrollment; patients who have received anti-tumor chemotherapy, molecular targeted therapy or immunotherapy before enrollment within 2 weeks or 5 half-lives from the first study dose (shorter);
- Participated in clinical trials of other new drugs within 4 weeks before enrollment;
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- Concurrently treated, or who has been treated with HER2 tyrosine kinase inhibitors(including lapatinib, neratinib, pyrotinib, etc.);
- History of other malignant tumours within 3 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma , skin squamous cell carcinoma or papillary thyroid carcinoma;
- There are serious and/or uncontrolled complications that may affect participation, including any of the following:1) Dysphagia, chronic diarrhoea and intestinal obstruction and factors that affect the administration and absorption of the drug;2) Allergic constitution; allergic to the study drug; history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases; history of organ transplantation;3) History of severe heart disease, including: myocardial infarction and heart failure; any other heart disease that is not suitable for participation (investigator assessment);4) Infection;
- Female patients during pregnancy and lactation; fertile female patients who tested positive on a baseline pregnancy test; female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial.
- Any other circumstances that are not suitable for inclusion in this study (investigator assessment)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug Conjugate(ADC): a Prospective, Single Arm, Trial
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs
Read the detailed description
To evaluate the efficacy and safety of pyrotinib plus capecitabine in Human Epidermal Growth Factor Receptor 2（HER2）-positive breast cancer patients with active brain metastases that have failed Antibody Drug Conjugates（Fam-trastuzumab deruxtecan-nxki[T-DXd] or A1811), had received no local radiotherapy previously and have at least one measurable brain lesion according to response assessment in neuro-oncology (RANO)criteria.
- Conditions
- Metastatic Breast Cancer in the Brain
- Being tested
- pyrotinib plus capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib plus capecitabineDrug
Also called SHR1258
oral
| Study group | Role | What they receive |
|---|---|---|
| Arms and Interventions | Experimental | HER2-positive: pyrotinib plus capecitabine Receives: Drug: pyrotinib plus capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate of Intracranial Lesion (CNS-ORR) by investigator
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Measured: 2 months
Secondary outcomes (3)
Clinica Benifit Rate of Intracranial Lesion(CNS-CBR) by investigator
CNS-CBR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Measured: 6 months
Disease Control Rate（DCR）by investigator
DCR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Measured: 6 months
Progression-Free Survival (PFS)
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer in the BrainStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475443
- Sponsor's protocol ID
- HNCH-MBC14-BM 05
- Status last verified
- Dec 2023
- First submitted
- 22 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug Conjugate(ADC): a Prospective, Single Arm, Trial
- ClinicalTrials.gov ID
- NCT06475443
- Acronym / sponsor ID
- HNCH-MBC14-BM 05
- Conditions
- Metastatic Breast Cancer in the Brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs
Detailed description
To evaluate the efficacy and safety of pyrotinib plus capecitabine in Human Epidermal Growth Factor Receptor 2（HER2）-positive breast cancer patients with active brain metastases that have failed Antibody Drug Conjugates（Fam-trastuzumab deruxtecan-nxki[T-DXd] or A1811), had received no local radiotherapy previously and have at least one measurable brain lesion according to response assessment in neuro-oncology (RANO)criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arms and Interventions | Experimental | Drug: pyrotinib plus capecitabineHER2-positive: pyrotinib plus capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- Pathologically confirmed HER2-positive invasive breast cancer with metastatic disease; patients with no pathological or cytologically confirmed metastatic disease should obtain clear evidence of metastasis through physical examination or radiological examination; Note: Positive HER2 -positive refers in the pathological examination/rechecking of primary lesions or metastatic lesions performed by the Research site's Pathology Laboratory, at least once the tumour cells defined as 3+ staining by immunohistochemistry, or fluorescence in situ hybridization (FISH) confirmed positive;
- Fam-trastuzumab deruxtecan-nxki or A1811 had failed treatment for active brain metastasis and had received no local radiotherapy previously. Patients with new lesions in the brain after craniotomy are allowed to be included, provided that radiotherapy is not performed after surgery;
- Enhanced MRI confirmed brain metastasis. According to RANO criteria, there is at least one measurable brain lesion, and the measurability of extracranial lesions is not required;
Key exclusion criteria (11 listed)
- Previous treatment for active brain metastases included other anti-tumor therapy except for T-DXd or A1811;
- Active brain metastases requiring radiotherapy; Patients with leptomeningeal metastasis (diagnosed by imaging/positive cerebrospinal fluid cytology) or a clear indication of clinically significant leptomeningeal involvement;
- Central Nervous System(CNS) complications that require urgent neurosurgical intervention (e.g. resection, shunt placement). Patients with poorly response brain metastases after dehydration treatment and glucocorticoid treatment, such as uncontrollable increase in intracranial pressure, jet vomiting, mental disorders, epilepsy, cognitive impairment, etc;
- Third space fluid that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites);
- Patients who have received anti-tumor radiotherapy or surgery within 2 weeks before enrollment (minor surgery, such as tumor biopsy, thoracentesis,intravenous catheterization or the like are allowed); patients who have received endocrine therapy within 1 week before enrollment; patients who have received anti-tumor chemotherapy, molecular targeted therapy or immunotherapy before enrollment within 2 weeks or 5 half-lives from the first study dose (shorter);
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 plus capecitabineAlso: SHR1258oral | Drug | Arms and Interventions |
Primary outcome
Objective Response Rate of Intracranial Lesion (CNS-ORR) by investigator
Time frame: 2 months
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
3 secondary outcomes
Clinica Benifit Rate of Intracranial Lesion(CNS-CBR) by investigator
Time frame: 6 months
Disease Control Rate（DCR）by investigator
Time frame: 6 months
Progression-Free Survival (PFS)
Time frame: 1.5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pyrotinib plus capecitabine in people with Metastatic Breast Cancer in the Brain, run by Henan Cancer 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 26 Jun 2024. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan, Professor (+86 15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of Intracranial Lesion (CNS-ORR) by investigator (time frame: 2 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 26 Jun 2024.