Actively Recruiting
Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer
Led by Henan Cancer Hospital · Updated on 2024-12-17
71
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
CONDITIONS
Official Title
Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female initial treatment patients aged 65 18 years and 64 70 years
- ECOG performance status score of 0 or 1
- Pathologically confirmed invasive breast cancer with tumor stage II to IIIA
- Hormone receptor positive and HER2 positive breast cancer
- Normal main organ function meeting specific blood, biochemical, and cardiac ultrasound standards
- Premenopausal or surgically sterilized females agree to use effective contraception during treatment and for at least 7 months after last dose
- Voluntary participation with signed informed consent
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Inflammatory breast cancer
- Prior anti-tumor or radiation therapy for any malignant tumor except cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma
- Concurrent anti-tumor therapies in other clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or incomplete recovery from such surgery
- Clinically significant lung diseases including interstitial pneumonia, pneumonia, pulmonary fibrosis, or radiation pneumonia requiring treatment
- Serious heart diseases including heart failure, systolic dysfunction (LVEF <50%), high-risk uncontrolled arrhythmia, angina requiring treatment, significant heart valve disease, transmural myocardial infarction, or poorly controlled hypertension
- Conditions affecting swallowing or drug absorption
- Known allergies to study drugs or history of immunodeficiency or organ transplantation
- Pregnant or lactating females, positive pregnancy test, or unwillingness to use contraception during and for 7 months post study
- Severe comorbidities or other conditions making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan cacer hospital
Henan, Henan, China, 450008
Actively Recruiting
Research Team
Z
Zhenzhen Liu
CONTACT
D
Dechuang Jiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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