Actively Recruiting
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
Led by Zhejiang Cancer Hospital · Updated on 2026-03-06
600
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Histologically confirmed HER2-positive advanced or metastatic breast cancer
- At least one measurable metastatic lesion confirmed by MRI or contrast-enhanced CT
- For prior trastuzumab or tyrosine kinase inhibitor treatment in early-stage, recurrence must be more than 1 year after treatment completion
- ECOG performance status score between 0 and 2
- Patients meeting treatment criteria who may have received or not received trastuzumab, pertuzumab, tyrosine kinase inhibitors, and may include those with brain metastases
- Voluntarily signed informed consent with good compliance
You will not qualify if you...
- Allergy to drugs or excipients used in this trial
- Current or recent use of medications affecting pyrotinib or trastuzumab metabolism, including strong CYP3A4 inhibitors or inducers
- Pregnant or breastfeeding women
- Major surgery within 4 weeks before study drug start without full recovery
- Severe systemic diseases or uncontrolled infections
- Conditions posing serious risk or interfering with study completion, such as severe hypertension, diabetes, thyroid disorders, active hepatitis B/C, or other infections
- History of other cancers
- Psychiatric illness, cognitive impairment, or inability to follow protocol and follow-up
- Other investigator-determined conditions making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China, 310000
Actively Recruiting
Research Team
Z
Ziwen Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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