HER2 + Breast CancerPhase 2NCT07766772
Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer
A Phase 2 study testing Trastuzumab Rezetecan, Pyrotinib and trastuzumab in people with HER2 + Breast Cancer and Advanced Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2 + Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan, Pyrotinib and trastuzumab
- 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
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 Dec 2031
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- Patients with active central nervous system metastases who have not undergone surgery or radiation therapy, except those whose condition has been stable for at least one month after treatment and who have discontinued corticosteroids for more than 2 weeks.
- A history of other malignancies within the past 5 years, excluding cured cases of cutaneous basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.
- Presence of third-space fluid accumulation (e.g., large volume ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other means.
- Patients who have received surgery (defined as major cancer-related surgery), radiation therapy, chemotherapy, immunotherapy, molecularly targeted therapy, biological therapy, or participated in other drug clinical trials within 4 weeks prior to the first dose of study medication.
- Prior exposure to antibody-drug conjugates containing irinotecan derivatives as topoisomerase I inhibitors, such as T-DXd (DS-8201a).
- Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study medication.
Show all 14Show fewer
- History of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
- Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure (NYHA ≥ II), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction occurring within 6 months prior to the first dose.
- Known or suspected interstitial lung disease; presence of moderate to severe pulmonary conditions within 3 months prior to the first dose that could significantly impair respiratory function or interfere with assessment or management of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obstructive bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung diseases, or cancerous lymphangitis; any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, or prior history of pneumonectomy. Patients with a prior history of interstitial lung disease grade ≥3 are excluded from this study.
- Known hereditary or acquired bleeding tendency (e.g., hemophilia, coagulation disorders).
- Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal), cirrhosis; or severe infections requiring intravenous antibiotics, antivirals, or antifungal agents for control.
- According to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0), patients whose toxicity from prior anticancer treatments has not recovered to ≤Grade 1 (except alopecia; certain tolerable chronic Grade 2 toxicities may be allowed at the investigator's discretion, such as Grade 2 peripheral neuropathy).
- Known hypersensitivity to any of the investigational drugs, their excipients, or other monoclonal antibodies.
- Other serious physical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study or interfere with study outcomes, or patients deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Cancer Hosptial
Fuzhou, Fujian, 350004
Fan Wu, doctor, 18649757370, 925378390@qq.com
About this study
Official title: A Single-arm, Exploratory Clinical Study of Sequential Use of Regorafenib in Combination With Pegylated Tyrosine Kinase Inhibitor and Trastuzumab in Combination With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer
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.
- Conditions
- HER2 + Breast Cancer, Advanced Breast Cancer
- Being tested
- Trastuzumab Rezetecan, Pyrotinib, trastuzumab, Capecitabine, endocrinotherapy（doctor's choice）
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Administer intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle.
PyrotinibDrug
Take orally once daily, 400 mg each time.
trastuzumabDrug
Intravenous infusion: Initial dose 8mg/kg, subsequent dose 6mg/kg, 3 weeks as one cycle; Subcutaneous injection: Fixed dose 600mg (not based on the subject's weight), administration completed within 2-5 minutes, 3 weeks as one cycle.
CapecitabineDrug
Oral administration, 3 times a day, 500 mg each time
endocrinotherapy（doctor's choice）Drug
Administer the medication according to the recommended regimen specified in the doctor's instructions for endocrine therapy. For patients with HR-positive disease, they can choose to use
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group | Experimental | After receiving Trastuzumab Rezetecan for Injection induction therapy, a combined treatment regimen of pyrotinib, trastuzumab, and capecitabine ± endocrine therapy was used for maintenance treatment. Receives: Drug: Trastuzumab Rezetecan; Drug: Pyrotinib; Drug: trastuzumab; Drug: Capecitabine; Drug: endocrinotherapy（doctor's choice） |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival(PFS)
The duration from the start of the induction period treatment to the observation of disease progression or the occurrence of death due to any cause.
Measured: From enrollment to 3 years
Secondary outcomes (5)
objective remission rate(ORR)
The proportion of patients with a therapeutic response evaluated as Complete Response(CR) and Partial Response(PR)
Measured: From enrollment to 3 years
duration of response(DoR)
It refers to the time period from the first evaluation as CR or PR (with the earlier occurrence taking precedence) until disease progression or death. The assessment is conducted using the RECIST 1.1 standard.
Measured: From enrollment to 3 years
Clinical Benefit Rate(CBR)
The proportion of patients whose tumor volume has decreased by 30% or whose disease has remained stable (SD) for 24 weeks since the start of the assessment, which is the sum of the proportions of complete response (CR), partial response (PR), and disease stability (SD) maintained for 24 weeks as evaluated by the investigators based on the RECIST 1.1 standard.
Measured: From enrollment to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Through blood routine tests (such as hemoglobin, white blood cell count, neutrophil count, platelet count, etc.), liver and kidney function tests (such as albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, urea nitrogen, creatinine, etc.), urine routine (such as urine protein, urine red blood cells, etc.), stool routine (stool occult blood), electrocardiogram (such as heart rate, QTc interval, etc.), echocardiography (left ventricular ejection fraction), etc., evaluate the changes in the values of corresponding tests during the treatment period. Classify and record the number of occurrences through CTCAE V5.0.
Measured: From the time of enrollment until 30 days after the completion of the study
Overall Survival(OS)
The duration from the start of the induction period treatment to the observation of any cause-related death
Measured: From enrollment to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 + Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wu Fang, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766772
- Sponsor's protocol ID
- OBU-BC-II-345
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of Sequential Use of Regorafenib in Combination With Pegylated Tyrosine Kinase Inhibitor and Trastuzumab in Combination With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07766772
- Acronym / sponsor ID
- OBU-BC-II-345
- Conditions
- HER2 + Breast Cancer, Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Aug 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group | Experimental | Drug: Trastuzumab Rezetecan, Drug: Pyrotinib, Drug: trastuzumab, Drug: Capecitabine, Drug: endocrinotherapy（doctor's choice）After receiving Trastuzumab Rezetecan for Injection induction therapy, a combined treatment regimen of pyrotinib, trastuzumab, and capecitabine ± endocrine therapy was used for maintenance treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female participants aged 18 to 75 years (inclusive)
- Breast cancer must meet the following criteria:
- ECOG performance status of 0 or 1.
- Organ function deemed adequate for study drug administration by the investigator.
- Pregnancy and contraception:
Key exclusion criteria (14 listed)
- Patients with active central nervous system metastases who have not undergone surgery or radiation therapy, except those whose condition has been stable for at least one month after treatment and who have discontinued corticosteroids for more than 2 weeks.
- A history of other malignancies within the past 5 years, excluding cured cases of cutaneous basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.
- Presence of third-space fluid accumulation (e.g., large volume ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other means.
- Patients who have received surgery (defined as major cancer-related surgery), radiation therapy, chemotherapy, immunotherapy, molecularly targeted therapy, biological therapy, or participated in other drug clinical trials within 4 weeks prior to the first dose of study medication.
- Prior exposure to antibody-drug conjugates containing irinotecan derivatives as topoisomerase I inhibitors, such as T-DXd (DS-8201a).
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 RezetecanAdminister intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle. | Drug | Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group |
| PyrotinibTake orally once daily, 400 mg each time. | Drug | Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group |
| trastuzumabIntravenous infusion: Initial dose 8mg/kg, subsequent dose 6mg/kg, 3 weeks as one cycle; Subcutaneous injection: Fixed dose 600mg (not based on the subject's weight), administration completed within 2-5 minutes, 3 weeks as one cycle. | Drug | Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group |
| CapecitabineOral administration, 3 times a day, 500 mg each time | Drug | Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group |
| endocrinotherapy（doctor's choice）Administer the medication according to the recommended regimen specified in the doctor's instructions for endocrine therapy. For patients with HR-positive disease, they can choose to use | Drug | Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group |
Primary outcome
progression free survival(PFS)
Time frame: From enrollment to 3 years
The duration from the start of the induction period treatment to the observation of disease progression or the occurrence of death due to any cause.
5 secondary outcomes
objective remission rate(ORR)
Time frame: From enrollment to 3 years
duration of response(DoR)
Time frame: From enrollment to 3 years
Clinical Benefit Rate(CBR)
Time frame: From enrollment to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the time of enrollment until 30 days after the completion of the study
Overall Survival(OS)
Time frame: From enrollment to 3 years
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 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for HER2 + Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan, Pyrotinib and trastuzumab in people with HER2 + Breast Cancer and Advanced Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
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 11 inclusion and 14 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Fan Wu, doctor (13859082118, alienglass@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival(PFS) (time frame: From enrollment to 3 years). 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 14 Aug 2026.