Actively Recruiting
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2020-11-30
516
Participants Needed
1
Research Sites
530 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Capecitabine combined with pyrotinib is the standard protocol for HR+/HER2+ advanced breast cancer after trastuzumab failure, but the incidence of grade 3 hand-foot-syndrome was 16.4%. Therefore, the search for efficient and low toxicity alternatives has become a research hotspot. Our previous basic studies have shown that ER inhibitor fulvestrant and HER2 inhibitor pyrotinib have a synergistic effect. The preliminary analysis of our prospective shows that the efficacy is close to that of capecitabine combined with pyrotinib, and the adverse events are significantly improved compared with capecitabine combined with pyrotinib. Therefore, it is necessary to further carry out a head-to-head phase III randomized controlled clinical trial to study the efficacy and safety of fulvestrant combined with pyrotinib in the treatment of HR + / HER2 + advanced breast cancer.
CONDITIONS
Official Title
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 80 years with metastatic breast cancer confirmed by pathology or imaging, not suitable for surgery or radiotherapy to cure
- Tumor tested positive for estrogen receptor (ER) and/or progesterone receptor (PR) (≥10% staining) and HER2 positive (immunohistochemical 3+ or FISH positive)
- Postmenopausal status or premenopausal patients treated with bilateral ovariectomy or GnRHa drugs
- Disease-free interval more than 12 months after last trastuzumab treatment before tumor progression
- Received no or only first-line trastuzumab treatment for metastatic disease with effective response
- Previous chemotherapy or endocrine therapy for adjuvant or metastatic disease with progression during or after treatment
- WHO physical status score 0-2 and expected survival of at least 3 months
- At least one measurable lesion detected by imaging within 2 weeks before enrollment
- Previous treatment toxicities reduced to NCI CTCAE version 5.0 grade 1 or less (except hair loss or safe toxicities)
- Normal blood counts within one week before enrollment: WBC ≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L
- Normal liver, kidney, and heart function within one week before enrollment based on lab standards
- Left ventricular ejection fraction (LVEF) ≥55%, QTcF ≤470 ms
You will not qualify if you...
- No prior trastuzumab, chemotherapy, or endocrine therapy
- Central nervous system metastasis with symptoms
- Presence of visceral crisis
- Eligible for chemotherapy as judged by researchers
- Conditions affecting drug administration or absorption such as swallowing difficulties, chronic diarrhea, or intestinal obstruction
- Received radiotherapy, chemotherapy, endocrine therapy, surgery (except local puncture), or molecular targeted therapy within 4 weeks before enrollment
- Participation in other clinical trials within 4 weeks before enrollment
- Received more than first-line endocrine therapy, chemotherapy, or targeted therapy for metastatic disease
- Other malignant tumors in past 5 years except cured cervical carcinoma in situ or certain skin cancers
- Concurrent anti-tumor treatment
- Known allergy to study drugs or history of immunodeficiency diseases
- Severe heart conditions including heart failure, uncontrolled arrhythmias, or systolic blood pressure >180 mmHg or diastolic >100 mmHg
- Pregnant or breastfeeding women or positive pregnancy test
- Serious accompanying diseases that threaten safety or study completion
- History of neurological or mental disorders such as epilepsy or dementia
- Any other condition deemed unsuitable by researchers affecting safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Ying Wang
CONTACT
J
Jianli Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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