Breast CancerNCT07455188
A Study on the Efficacy and Safety of Switching Between Two Targeted Strategies, HP+Chemotherapy and HPy+Chemotherapy, After Treatment Progression in HER-2 Positive Advanced or Metastatic Breast Cancer
An observational study of Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Antitumor treatment plan
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2030
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER-2 positive advanced or metastatic breast cancer.
Who may be able to join
- Voluntarily signed the informed consent form with good compliance.
- Female, aged 18 years or older.
- Histologically confirmed diagnosis of HER2-positive advanced or metastatic breast cancer.
- Metastatic lesions confirmed by MRI/contrast-enhanced CT, with at least one measurable lesion according to RECIST 1.1 criteria.
- For patients previously treated with trastuzumab or tyrosine kinase inhibitors (TKIs) in the early-stage setting, recurrence must have occurred more than 1 year after the completion of prior treatment.
- ECOG performance status score of 0-2.
- Eligible patients meeting the treatment criteria specified in this study protocol may be included. This includes:Patients whose prior first-line and second-line treatments both align with the requirements of this protocol；Patients currently receiving second-line treatment whose prior first-line treatment aligns with the requirements of this protocol；The above populations may have previously received or not received trastuzumab and/or pertuzumab, small-molecule tyrosine kinase inhibitors (e.g., pyrotinib, etc.), and may include patients with brain metastases, among others.
- -
Who cannot join
- Known allergy to the drugs involved in this trial or their excipients.
- Current or recent use of medications that may affect the metabolism or efficacy of pyrotinib or trastuzumab, such as strong CYP3A4 inhibitors (e.g., itraconazole, fluconazole, etc.), strong CYP3A4 inducers (e.g., rifampicin, efavirenz, etc.), or other drugs that may influence the plasma concentration of these two agents.
- Pregnant or lactating women.
- Major surgery within 4 weeks prior to the start of study drug administration, with incomplete recovery. Minor procedures such as tumor biopsy, thoracentesis, or venous catheter placement are permitted.
- Presence of severe systemic diseases and/or uncontrolled infections.
- Concurrent conditions considered by the investigator to pose a serious risk to patient safety or interfere with the patient's ability to complete the study (e.g., severe hypertension, diabetes, thyroid disorders, concurrent hepatitis B/C, or other active infections).
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- History of other malignancies.
- Psychiatric illness, cognitive impairment, or inability to comply with the trial protocol and follow-up.
- Other conditions deemed by the investigator to render the participant unsuitable for inclusion.
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, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310000
Ziwen Zhang, +86 13588318799, 16660496@qq.com
About this study
This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening/baseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.
- Conditions
- Breast Cancer
- Being tested
- Antitumor treatment plan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antitumor treatment planDrug
This research project included valid data from 600 patients with HER-2 positive advanced or metastatic breast cancer. They were randomly divided into Group A (transition from HP + chemotherapy to HPy + chemotherapy) or Group B (transition from HPy + chemotherapy to HP + chemotherapy) in a 1:1 ratio. Each group had approximately 300 patients. If the patients failed in their first-line treatment, they would switch to another treatment regimen in the second-line treatment. All patients were stopped from treatment when their condition progressed, toxicity became intolerable, or for other reasons. The treatment cycles were recorded.
| Study group | Role | What they receive |
|---|---|---|
| B | The treatment plan was changed from HPy plus chemotherapy to HP plus chemotherapy. Receives: Drug: Antitumor treatment plan | |
| A | The treatment plan was changed from HP plus chemotherapy to HPy plus chemotherapy. Receives: Drug: Antitumor treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS by Investigator assessment per RECIST 1.1
The PFS of patients who had previously received trastuzumab treatment and then switched to another targeted therapy after progression following two targeted strategies after recurrence.
Measured: 60 mouths
Secondary outcomes (1)
Overall survival (OS)
The OS of patients after conversion application of two targeted strategies in the treatment of post-progression cases.
Measured: 60 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2025
- Primary completion31 Dec 2030 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Hai, Zhejiang Cancer Hospital
- Investigators
- Hai Hu, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455188
- Sponsor's protocol ID
- IIT-2025-109
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Switching Between Two Targeted Strategies, HP+Chemotherapy and HPy+Chemotherapy, After Treatment Progression in HER-2 Positive Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07455188
- Acronym / sponsor ID
- IIT-2025-109
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Mar 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 adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening/baseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | – | Drug: Antitumor treatment planThe treatment plan was changed from HPy plus chemotherapy to HP plus chemotherapy. |
| A | – | Drug: Antitumor treatment planThe treatment plan was changed from HP plus chemotherapy to HPy plus chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER-2 positive advanced or metastatic breast cancer.
Key inclusion criteria (8 listed)
- Voluntarily signed the informed consent form with good compliance.
- Female, aged 18 years or older.
- Histologically confirmed diagnosis of HER2-positive advanced or metastatic breast cancer.
- Metastatic lesions confirmed by MRI/contrast-enhanced CT, with at least one measurable lesion according to RECIST 1.1 criteria.
- For patients previously treated with trastuzumab or tyrosine kinase inhibitors (TKIs) in the early-stage setting, recurrence must have occurred more than 1 year after the completion of prior treatment.
Key exclusion criteria (9 listed)
- Known allergy to the drugs involved in this trial or their excipients.
- Current or recent use of medications that may affect the metabolism or efficacy of pyrotinib or trastuzumab, such as strong CYP3A4 inhibitors (e.g., itraconazole, fluconazole, etc.), strong CYP3A4 inducers (e.g., rifampicin, efavirenz, etc.), or other drugs that may influence the plasma concentration of these two agents.
- Pregnant or lactating women.
- Major surgery within 4 weeks prior to the start of study drug administration, with incomplete recovery. Minor procedures such as tumor biopsy, thoracentesis, or venous catheter placement are permitted.
- Presence of severe systemic diseases and/or uncontrolled infections.
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 |
|---|---|---|
| Antitumor treatment planThis research project included valid data from 600 patients with HER-2 positive advanced or metastatic breast cancer. They were randomly divided into Group A (transition from HP + chemotherapy to HPy + chemotherapy) or Group B (transition from HPy + chemotherapy to HP + chemotherapy) in a 1:1 ratio. Each group had approximately 300 patients. If the patients failed in their first-line treatment, they would switch to another treatment regimen in the second-line treatment. All patients were stopped from treatment when their condition progressed, toxicity became intolerable, or for other reasons. The treatment cycles were recorded. | Drug | A, B |
Primary outcome
PFS by Investigator assessment per RECIST 1.1
Time frame: 60 mouths
The PFS of patients who had previously received trastuzumab treatment and then switched to another targeted therapy after progression following two targeted strategies after recurrence.
1 secondary outcome
Overall survival (OS)
Time frame: 60 mouths
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 6 Mar 2026.
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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.
Hai Hu principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Zhejiang 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Mar 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.
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 Ziwen Zhang (+86 13588318799, 16660496@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS by Investigator assessment per RECIST 1.1 (time frame: 60 mouths). 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 6 Mar 2026.