Study of Trastuzumab Deruxtecan (DS-8201a, T-DXd) versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting
- Conditions
- HER2-Low, Hormone Receptor Positive Breast Cancer which has Progressed on Endocrine Therapy in the Metastatic Setting.
- Registration Number
- 2024-516653-44-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
To assess the efficacy of Trastuzumab deruxtecan (T-DXd) compared with investigator's choice chemotherapy in terms of PFS by BICR in the HR+, HER2-low (IHC 2+/ISH- and IHC 1+) populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 250
Patients must be ≥18 years of age.
Pathologically documented breast cancer that: a. is advanced or metastatic b. Has a history of HER2-low or negative expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or IHC 0 (ISH- or untested) c. Has HER2-low expression or HER2 IHC >0 <1+ expression as determined by the central laboratory result from a metastatic setting d. was never previously HER2-positive e. has documented HR+ disease in the metastatic disease setting.
Has adequate tumor samples for assessment of HER2 status
Disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy (Progression of disease within 24 months on adjuvant ET is considered a line of therapy) or disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator.
No prior chemotherapy for advanced or metastatic breast cancer.
Has protocol-defined adequate organ and bone marrow function. The most recent results must be used to meet this inclusion criteria
Ineligible for all options in the investigator's choice chemotherapy arm. Patients with contraindications to capecitabine, paclitaxel, and nabpaclitaxel treatment, per local prescribing information, cannot be enrolled
Uncontrolled intercurrent illness or significant cardiovascular disease
Active or prior documented ILD/pneumonitis that required steroids or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Lung-specific intercurrent clinically significant illnesses
Patients with spinal cord compression or active clinically central nervous system metastasis.
Concurrent enrolment in another clinical study, unless it is: - an observational (non-interventional) clinical study - during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)
Have received a study treatment from a prior interventional study, administered in the last 30 days prior to first dose of this study treatment
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) - in HR+ HER2-low population Overall Survival (OS) - in HR+ HER2-low population
Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2 IHC >0 <1+ and HER2-low) Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2 IHC >0 <1+ and HER2-low)
OS - in ITT population (HER2 IHC >0 <1+ and HER2-low) OS - in ITT population (HER2 IHC >0 <1+ and HER2-low)
Objective Response Rate (ORR) and Duration of response (DoR) - in HR+, HER-2 low population Objective Response Rate (ORR) and Duration of response (DoR) - in HR+, HER-2 low population
PFS by Investigator assessment - in the HR+, HER2-low population PFS by Investigator assessment - in the HR+, HER2-low population
ORR and DoR - in the ITT population ORR and DoR - in the ITT population
PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population
Safety and tolerability of T-DXd compared to chemotherapy Safety and tolerability of T-DXd compared to chemotherapy
The pharmacokinetics (PK) of T-Dxd The pharmacokinetics (PK) of T-Dxd
Health-related quality of life Health-related quality of life
Immunogenicity of T-Dxd Immunogenicity of T-Dxd
Trial Locations
- Locations (81)
Vitaz
🇧🇪Sint-Niklaas, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Algemeen Ziekenhuis Delta
🇧🇪Roeselare, Belgium
Grand Hopital De Charleroi
🇧🇪Charleroi, Belgium
Centre hospitalier universitaire de Liege
🇧🇪Liege, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
🇧🇪Namur, Belgium
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Scroll for more (71 remaining)Vitaz🇧🇪Sint-Niklaas, BelgiumInes DeleuSite contact003237602985ines.deleu@vitaz.be