Combining hydroxychloroquine with antibody-drug conjugates for advanced breast cancer treatment
Open, Controlled, Multicenter Phase I/II Clinical Study of Hydroxychloroquine in Combination With Antibody-drug Conjugate Versus Antibody-drug Conjugate for Advanced Breast Cancer.
This study is testing if adding hydroxychloroquine to two targeted cancer treatments can help people with advanced breast cancer who haven't responded to other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, Trastuzumab, Sacituzumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06328387 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining hydroxychloroquine with two antibody-drug conjugates, Trastuzumab Deruxtecan and Sacituzumab Govitecan, in treating patients with advanced breast cancer who have not responded to first-line therapies. The study aims to explore the potential synergistic effects of hydroxychloroquine, an FDA-approved autophagy inhibitor, alongside these novel ADCs, which target specific cancer markers with high efficacy and low toxicity. Patients will be monitored for progression-free survival and overall response to the treatment regimen. The trial includes both Phase 1 and Phase 2 assessments to evaluate safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 70 with a confirmed diagnosis of advanced breast cancer who have failed first-line treatment.
Not a fit: Patients who have not been diagnosed with advanced breast cancer or those who have already received more than three chemotherapy regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with advanced breast cancer.
How similar studies have performed: Previous studies have shown promising results with similar combinations of ADCs and autophagy inhibitors, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of advanced breast cancer (female, 18 to 70 years old). 2. Pathological confirmed advanced breast cancer. 3. The patient is willing to receive SG or T-DXd treatment. 4. Failure of first-line treatment. 5. Have received no more than 3 chemotherapy schemes for metastatic breast cancer in the past. 6. ECOG physical condition score ≤ 2 points, estimated survival time of no less than 3 months. 7. At least one measurable lesion should be present in the imaging examination within 2 weeks prior to enrollment; Or simple bone metastasis lesions. 8. LVEF≥50%. 9. Previous treatment related toxicity must be relieved to NCI CTCAE (version 5.0) ≤ 1 degree, AST and ALT ≤ 2.5 times the upper limit of normal value, and total bilirubin ≤ 1.5 times the upper limit of normal value. 10. Adequate reserve of bone marrow function: white blood cell count ≥ 3.0 × 10\^9/L, neutrophil count ≥ 1.5 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥ 90g/L; Serum creatinine ≤ 1.5 times the upper limit of normal value. Exclusion Criteria: 1. Patients suffer from various factors such as difficulty swallowing and chronic diarrhea, which affect medication intake and absorption. 2. Individuals with severe heart disease or discomfort, expected inability to tolerate chemotherapy, including but not limited to: fatal arrhythmias or higher-level atrioventricular block, unstable angina, clinically significant valvular heart disease, electrocardiogram showing transmural myocardial infarction, and uncontrolled hypertension. 3. Patients who are known to be allergic to the active ingredients or other components of the investigational drug. 4. Received radiotherapy, chemotherapy, endocrine therapy within 4 weeks prior to enrollment, or is currently participating in any intervention drug clinical trials. 5. Pregnant or lactating women, women of childbearing age who refuse to take effective contraceptive measures during the study period. 6. The researchers believe that patients are not suitable to participate in any other circumstances of this study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jianli J Zhao, doctorate — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Jianli J Zhao, doctorate
- Email: zhaojli5@mail.sysu.edu.cn
- Phone: 15920589334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.