A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT04556773
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Patients must be at least 18 years of age<br><br> - Male or female patients who have pathologically documented breast cancer that:<br><br> 1. Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or<br> untested) with a validated assay<br><br> 2. Is documented as HR+ (either ER and/or PgR positive [ER or PgR =1%]) or ER and<br> PgR negative (ER and PgR <1%) per ASCO/CAP guidelines in the metastatic setting<br><br> - Patient must have adequate tumor sample for biomarker assessment<br><br> - ECOG Performance Status of 0 or 1<br><br>For patients with HR+ disease:<br><br>Part 1: At least 1 prior treatment line of ET with or without a targeted therapy (such as<br>CDK4/6, mTOR or PI3-K inhibitors), and at least 1 prior line of chemotherapy for MBC are<br>required.<br><br>Part 2: Only 1 prior treatment line of ET with or without a targeted therapy (such as<br>CDK4/6, mTOR or PI3-K inhibitors) for MBC is allowed. No prior chemotherapy in the<br>metastatic setting is allowed. Note there are no patients with HR+ disease in Part 2 of<br>Modules 2 and 3.<br><br>For patients with HR- disease:<br><br>Part 1: At least 1 prior line of chemotherapy for MBC is required. Note there are no<br>patients with HR- disease in Part 1 of Modules 4 and 5.<br><br>Part 2: For Module 2, no prior lines of therapy for MBC are allowed, and for Modules 1<br>and 3, only 1 prior line of chemotherapy for MBC is allowed. Note there are no patients<br>with HR- disease in Part 2 of Modules 4 and 5.<br><br>Key Exclusion Criteria:<br><br> - Uncontrolled intercurrent illness<br><br> - Uncontrolled or siginificant cardiovascular disease<br><br> - History of (non-infectious) ILD/pneumonitis that required steroids, has current<br> ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging<br> at screening.<br><br> - Lung-specific intercurrent clinically significant illnesses<br><br> - Has spinal cord compression or clinically active central nervous system metastases<br><br> - Active primary immunodeficiency<br><br> - Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals<br><br> - Prior treatment with ADC that comprises of an exatecan derivative that is a<br> topoisomerase I inhibitor.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of adverse events (AEs)- Part 1;Occurrence of serious adverse events (SAEs)- Part 1;Occurrence of adverse events (AEs)- Part 2;Occurrence of serious adverse events (SAEs)- Part 2
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR)- Part 2;Progression Free Survival (PFS)- Part 2;Duration of Response (DoR)- Part 2;Overall Survival (OS)- Part 2;Serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a;Immunogenicity of trastuzumab deruxtecan;Serum Concentration of durvalumab;Immunogenicity of durvalumab