NCT07019337Not yet recruitingPhase 2
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 30 Jun 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07019337
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 30 Jun 2025 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a TKI or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting.
Other illness
- 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;
Lab values
- Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results
Other
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pregnant or lactating patients;
- Deemed by the investigator to be ineligible for participation in the study.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.