Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-… (NCT07766772) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer
China50 participantsStarted 2026-09-30
Plain-language summary
This study is a single-arm, exploratory clinical trial, aiming to include patients with HER2-positive advanced breast cancer. It intends to explore the efficacy and safety of trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy as a first-line maintenance treatment for HER2+ advanced breast cancer after induction therapy with rucaparib trastuzumab.
After the subjects meet the screening criteria and are enrolled, they receive induction therapy with rucaparib trastuzumab. Among them, patients without disease progression enter the maintenance treatment period and receive trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy (±OFS) for treatment. Until disease progression, or toxicity becomes intolerable, or withdrawal of informed consent, or the investigator determines that the medication must be discontinued. During the study period, imaging evaluations are conducted according to the RECIST 1.1 standard, and the center assessment results are the final results.
During the study period, the efficacy indicators such as PFS, ORR, DOR, CBR, and safety indicators of the subjects are evaluated according to the established trial standards, and statistical descriptions are conducted.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female participants aged 18 to 75 years (inclusive)
* Breast cancer must meet the following criteria:
* HER2-positive breast cancer confirmed by histology or cytology (HER2 positivity defined as IHC 3+ or ISH+ in primary or metastatic lesions); locally advanced or metastatic breast cancer not amenable to curative surgery (participants eligible for curative treatment are excluded);
* Clear HR status (HR-positive defined as ER and/or PR positive in primary or metastatic lesions, with ≥1% of tumor cells showing ER and/or PR staining);
* No prior systemic anticancer therapy during the recurrent/metastatic phase (except ≤1 line of endocrine therapy allowed);
* For patients receiving (neo)adjuvant therapy, the interval between completion of systemic therapy (excluding endocrine therapy) and detection of recurrence/metastasis must be \>12 months.
* ECOG performance status of 0 or 1.
* Organ function deemed adequate for study drug administration by the investigator.
* Pregnancy and contraception:
• Sexually active female participants (WOCBP) must agree to use highly effective contraception from the screening visit through 7 months after the last dose of investigational product, and must agree not to breastfeed.
* Participants must voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and be willing to cooperate with all study visits and procedures.
Exclusion Criteria:
* Patients with active central nervous system met…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.