CompletedPhase 2

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

Portugal, Spain41 participantsStarted 2020-05-25

Plain-language summary

This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
✓. Male or female patients ≥ 18 years at the time of signing ICF.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 for Cohorts 1 to 4 and 0-2 for cohort 5.
✓. Life expectancy ≥ 12 weeks.
✓. Histologically confirmed invasive breast cancer based on local testing on the most recent analyzed biopsy of the following breast cancer (BC) subtypes per 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria:
✓. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
✓. At least one brain lesion needed to be measurable (≥10 mm on T1-weighted, gadolinium-enhanced MRI) (study cohorts 2 to 4) or leptomeningeal carcinomatosis (LMC) with positive cerebrospinal fluid (CSF) cytology (study cohort 5).
✓. Previous treatments:

✕. Inability to comply with study and follow-up procedures.
✕. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor.
✕. Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction within 28 days prior to enrollment.
✕. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (males) based on average of the screening triplicate12- lead ECG.
✕. History of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD, or where suspected ILD cannot be ruled out by imaging at screening.
✕. Clinically significant corneal disease in the opinion of the Investigator.
✕. Spinal cord compression.
✕. Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

16 Weeks PFS Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) (Cohort 1)

Timeframe: From baseline up to 16 weeks

Objective Response Rate According RANO-BM (Cohorts 2, 3 and 4)

Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.

Overall Survival in Cohort 5

Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.

NCT IDNCT04420598

SponsorMedSIR

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

Results submitted2024-10-23

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
✓. Male or female patients ≥ 18 years at the time of signing ICF.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 for Cohorts 1 to 4 and 0-2 for cohort 5.
✓. Life expectancy ≥ 12 weeks.
✓. Histologically confirmed invasive breast cancer based on local testing on the most recent analyzed biopsy of the following breast cancer (BC) subtypes per 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria:
✓. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
✓. At least one brain lesion needed to be measurable (≥10 mm on T1-weighted, gadolinium-enhanced MRI) (study cohorts 2 to 4) or leptomeningeal carcinomatosis (LMC) with positive cerebrospinal fluid (CSF) cytology (study cohort 5).
✓. Previous treatments:

✕. Inability to comply with study and follow-up procedures.
✕. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor.
✕. Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction within 28 days prior to enrollment.
✕. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (males) based on average of the screening triplicate12- lead ECG.
✕. History of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD, or where suspected ILD cannot be ruled out by imaging at screening.
✕. Clinically significant corneal disease in the opinion of the Investigator.
✕. Spinal cord compression.
✕. Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

What they're measuring

16 Weeks PFS Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) (Cohort 1)

Timeframe: From baseline up to 16 weeks

Objective Response Rate According RANO-BM (Cohorts 2, 3 and 4)

Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.

Overall Survival in Cohort 5

Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.