Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
Recruiting · NCT06331169 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 1\. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:
- Is unresectable or metastatic.
- Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).
- Is HR-positive or HR-negative.
- Has progressed on, and would no longer benefit from, endocrine therapy.
- Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting.
- \. 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）.
- \. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
- \. 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
- Has previously been treated with anti-angiogenic targeted small molecule therapy.
- Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative.
- 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.
- Has unresolved toxicities from previous anticancer therapy.
- Has uncontrolled or significant cardiovascular disease.
- Has any bleeding event, unhealed wounds, ulcerative or fractures.
- Has arterial or venous thromboembolic events occurred within 6 months.
- Has spinal cord compression or clinically active central nervous system metastases.
- Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
Where it is running
1 location listed.
- Jian Zhang - Shanghai, Shanghai Municipality, China