HER2-positive Breast CancerPhase 2NCT07019337
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
A Phase 2 study testing Pyrotinib and Capecitabine in people with HER2-positive Breast Cancer and Metastatic Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Pyrotinib and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 and ≤75 years.
- Histologically or cytologically confirmed HER2-positive metastatic breast cancer.
- Patients must have either experienced disease progression following anti-HER2 antibody-drug conjugate (ADC) therapy in the advanced/metastatic setting (including regimens containing SHR-A1811, T-DXd, T-DM1, or other approved ADCs) or discontinued prior anti-HER2 ADC treatment due to intolerable toxicity, financial constraints, or patient preference without evidence of disease progression.
- ECOG performance status of 0 to 2.
- The functions of the main organs are basically normal
- Signed informed consent
Who cannot join
- Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;
- Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results
- Deemed by the investigator to be ineligible for participation in the study.
About this study
This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment.
- Being tested
- Pyrotinib, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
400mg or 320mg qd
CapecitabineDrug
500mg tid
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib plus capecitabine | Experimental | Patients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity. Receives: Drug: Pyrotinib; Drug: Capecitabine |
| pyrotinib and capecitabine | Experimental | Patients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity. Receives: Drug: Pyrotinib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: The observation period related to this endpoint is up to 36 months.
Secondary outcomes (4)
Objective response rate (ORR)
Measured: The observation period related to this endpoint is up to 36 months.
Clinical Benefit Rate (CBR)
Measured: The observation period related to this endpoint is up to 36 months.
Overall Survival (OS)
Measured: The observation period related to this endpoint is up to 36 months.
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Measured: From consent through 28 days following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2030 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019337
- Sponsor's protocol ID
- MA-BC-II-112
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07019337
- Acronym / sponsor ID
- MA-BC-II-112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jun 2025 (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 is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pyrotinib plus capecitabine | Experimental | Drug: Pyrotinib, Drug: CapecitabinePatients who experienced disease progression (PD) following front-line treatment with an ADC-based regimen received pyrotinib in combination with metronomic capecitabine until disease progression or unacceptable toxicity. |
| pyrotinib and capecitabine | Experimental | Drug: Pyrotinib, Drug: CapecitabinePatients without disease progression who discontinued front-line ADC therapy due to intolerable toxicity, economic reasons, or patient preference were enrolled and received pyrotinib plus metronomic capecitabine until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 and ≤75 years.
- Histologically or cytologically confirmed HER2-positive metastatic breast cancer.
- Patients must have either experienced disease progression following anti-HER2 antibody-drug conjugate (ADC) therapy in the advanced/metastatic setting (including regimens containing SHR-A1811, T-DXd, T-DM1, or other approved ADCs) or discontinued prior anti-HER2 ADC treatment due to intolerable toxicity, financial constraints, or patient preference without evidence of disease progression.
- ECOG performance status of 0 to 2.
- The functions of the main organs are basically normal
Key exclusion criteria (7 listed)
- Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;
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 |
|---|---|---|
| Pyrotinib400mg or 320mg qd | Drug | pyrotinib and capecitabine, pyrotinib plus capecitabine |
| Capecitabine500mg tid | Drug | pyrotinib and capecitabine, pyrotinib plus capecitabine |
Primary outcome
Progression Free Survival (PFS)
Time frame: The observation period related to this endpoint is up to 36 months.
4 secondary outcomes
Objective response rate (ORR)
Time frame: The observation period related to this endpoint is up to 36 months.
Clinical Benefit Rate (CBR)
Time frame: The observation period related to this endpoint is up to 36 months.
Overall Survival (OS)
Time frame: The observation period related to this endpoint is up to 36 months.
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Time frame: From consent through 28 days following treatment completion
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 13 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib and Capecitabine in people with HER2-positive Breast Cancer and Metastatic Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 6 inclusion and 7 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 13 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: The observation period related to this endpoint is up to 36 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 13 Jun 2025.