Actively Recruiting
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Led by Fudan University · Updated on 2024-08-30
42
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.
CONDITIONS
Official Title
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years with ECOG performance status 0 or 1
- Pathologically confirmed breast cancer that is unresectable or metastatic
- Breast cancer with low HER2 expression (IHC 1+ or IHC 2+/ISH- or 0<IHC<1+)
- Hormone receptor positive or negative breast cancer
- Disease progressed after endocrine therapy and no longer benefits from it
- Received at least one prior line of chemotherapy or adjuvant therapy in the recurrent or metastatic setting
- At least one measurable lesion per RECIST 1.1 criteria (lesions treated with radiotherapy or focal therapy without progression cannot be assessed)
- Adequate bone marrow, kidney, liver, and blood clotting function as defined by the protocol
- Male and female participants of reproductive potential must agree to use highly effective contraception or avoid intercourse during and for at least 6 months after the study
You will not qualify if you...
- Previous treatment with anti-angiogenic targeted small molecule therapy
- Prior treatment with antibody-drug conjugate containing a topoisomerase I inhibitor exatecan derivative
- History of noninfectious interstitial lung disease or pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging
- Unresolved toxicities from prior anticancer therapy
- Uncontrolled or significant cardiovascular disease
- Any bleeding events, unhealed wounds, ulcers, or fractures
- Arterial or venous thromboembolic events within 6 months
- Spinal cord compression or active central nervous system metastases
- Any other conditions deemed inappropriate for the study by the protocol or investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jian Zhang
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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