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DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Phase 2 trial testing Trastuzumab deruxtecan in Advanced Breast Cancer in 41 participants. Completed in 4 April 2023.
| Lead sponsor | MedSIR |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 25 May 2020 |
| Primary completion | 30 September 2021 |
| Estimated completion | 4 April 2023 |
| Sites | 16 locations across Portugal, Spain |
MedSIR — full company profile →
18 and older, any sex, with Advanced Breast Cancer or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This outcome measure evaluates progression-free survival (PFS) in Cohort 1 over a 16-week period, using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 7 |
The proportion of patients achieving either Complete Response (CR) or Partial Response (PR) at any assessment time point, based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria
| Group | Value | 95% CI |
|---|---|---|
| Cohort 2 | 3 | |
| Cohort 3 | 4 | |
| Cohort 4 | 3 | |
| Cohort 2 | 7 | |
| Cohort 3 | 5 | |
| Cohort 4 | 3 |
Median of OS rate for patients
| Group | Value | 95% CI |
|---|---|---|
| Cohort 5 | 13.3 | 2.5 – NA |
Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 2 | |
| Cohort 2 | 0 | |
| Cohort 3 | 0 | |
| Cohort 4 | 0 | |
| Cohort 5 | 1 | |
| Cohort 1 | 0 | |
| Cohort 2 | 7 | |
| Cohort 3 | 5 | |
| Cohort 4 | 3 | |
| Cohort 5 | 0 | |
| Cohort 1 | 2 | |
| Cohort 2 | 1 | |
| Cohort 3 | 1 | |
| Cohort 4 | 1 | |
| Cohort 5 | 3 | |
| Cohort 1 | 0 | |
| Cohort 2 | 2 | |
| Cohort 3 | 2 | |
| Cohort 4 | 2 | |
| Cohort 5 | 1 |
This outcome measure assesses the extra-cranial response of metastatic lesions outside the brain using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 4 | |
| Cohort 2 | 3 | |
| Cohort 3 | 2 | |
| Cohort 4 | 3 | |
| Cohort 5 | 0 | |
| Cohort 1 | 0 | |
| Cohort 2 | 0 | |
| Cohort 3 | 0 | |
| Cohort 4 | 0 | |
| Cohort 5 | 0 | |
| Cohort 1 | 2 | |
| Cohort 2 | 3 | |
| Cohort 3 | 3 | |
| Cohort 4 | 0 | |
| Cohort 5 | 5 | |
| Cohort 1 | 0 | |
| Cohort 2 | 3 | |
| Cohort 3 | 0 | |
| Cohort 4 | 3 | |
| Cohort 5 | 0 |
The global evaluation of tumor response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This includes classification into categories such as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), based on changes in tumor size and the appearance of new lesions.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 4 | |
| Cohort 2 | 3 | |
| Cohort 3 | 2 | |
| Cohort 4 | 2 | |
| Cohort 5 | 0 | |
| Cohort 1 | 0 | |
| Cohort 2 | 0 | |
| Cohort 3 | 0 | |
| Cohort 4 | 0 | |
| Cohort 5 | 0 | |
| Cohort 1 | 3 | |
| Cohort 2 | 3 | |
| Cohort 3 | 4 | |
| Cohort 4 | 1 | |
| Cohort 5 | 5 | |
| Cohort 1 | 0 | |
| Cohort 2 | 3 | |
| Cohort 3 | 2 | |
| Cohort 4 | 3 | |
| Cohort 5 | 1 |
The Clinical Benefit Rate (CBR) is a measure of the proportion of patients who achieve a clinically meaningful benefit from the treatment
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 1 | |
| Cohort 2 | 4 | |
| Cohort 3 | 3 | |
| Cohort 4 | 3 | |
| Cohort 5 | 2 | |
| Cohort 1 | 7 | |
| Cohort 2 | 6 | |
| Cohort 3 | 6 | |
| Cohort 4 | 3 | |
| Cohort 5 | 5 |
Time frame: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — |
| Intraventricular haemorrhage | Nervous system disorders | — | — | — | — | — |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Nervous system disorder | Nervous system disorders | — | — | — | — | — |
| Superinfection | Infections and infestations | — | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Dysarthria | Nervous system disorders | — | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — |
| Diplopia | Eye disorders | — | — | — | — | — |
| Disorientation | Psychiatric disorders | — | — | — | — | — |
| Oedema | General disorders | — | — | — | — | — |
| Abdominal pain lower | Gastrointestinal disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — | — |
| Electrocardiogram QRS complex prolonged | Investigations | — | — | — | — | — |
| Epigastric discomfort | Gastrointestinal disorders | — | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — | — |
Most-reported serious reactions: Pulmonary embolism, Deep vein thrombosis, COVID-19, Pneumonia, Intraventricular haemorrhage, Interstitial lung disease, Nausea, Nervous system disorder.
Data from ClinicalTrials.gov NCT04420598 adverse events section.
This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04420598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing