NCT06331169 Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
| NCT ID | NCT06331169 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fudan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2024-07-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 1\. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that: 1. Is unresectable or metastatic. 2. Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+). 3. Is HR-positive or HR-negative. 4. Has progressed on, and would no longer benefit from, endocrine therapy. 5. Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting. 3\. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）. 4\. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions. 5\. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months. Exclusion Criteria: 1. Has previously been treated with anti-angiogenic targeted small molecule therapy. 2. Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative. 3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 4. Has unresolved toxicities from previous anticancer therapy. 5. Has uncontrolled or significant cardiovascular disease. 6. Has any bleeding event, unhealed wounds, ulcerative or fractures. 7. Has arterial or venous thromboembolic events occurred within 6 months. 8. Has spinal cord compression or clinically active central nervous system metastases. 9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
Frequently Asked Questions
Who can join the NCT06331169 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06331169 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06331169 currently recruiting?
Yes, NCT06331169 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT06331169 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06331169 clinical trial?
NCT06331169 is sponsored by Fudan University. The trial plans to enroll 42 participants.
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