New study checks drug interactions for advanced breast cancer treatment
NCT ID NCT06710990
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two common drugs (ritonavir and itraconazole) change the way the body processes a new experimental drug called SHR-A1811 in people with advanced HER2-positive breast cancer. Seventeen participants received the drug alone and then with each of the other medications to measure safety and blood levels. The goal was to understand potential drug interactions, not to test if the drug works as a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ECOG score of 0 or 1; 2. Expected survival of not less than 3 months; 3. Important organ functions meet the following criteria: * Absolute neutrophil count (ANC) ≥1.5×109/L (1,500/mm3); * Platelet count (PLT) ≥100×109/L (100,000/mm3); * Hemoglobin (Hgb) ≥9.0 g/dL (90g/L); * Albumin level ≥3.0 g/dL; * Total serum bilirubin ≤1.5× the upper limit of normal (ULN); * Prothrombin time and activated partial thromboplastin time (aPTT) ≤1.5×ULN; * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN); * Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; * QTcF ≤470 msec; * Left ventricular ejection fraction (LVEF) ≥50%. Exclusion Criteria: 1. Known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for \>2 weeks; 2. Having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc. 3. Known severe allergic history to any component of the SHR-A1811 product (ADC, total antibody, unconjugated toxin SHR169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.); 4. Having contraindications to ritonavir or itraconazole use; 5. Having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510200, China
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