THE FASTER WE MOVE

MEDSIR at SEOM 2021: Update on the Recruitment Status of the DEBBRAH Study

The Spanish Society of Medical Oncology (Sociedad Española de Oncologia MedicaSEOM) is a non-profit organization composed by around 3000 oncologists in Spain, aimed at improving cancer prevention, diagnosis, treatment, and patients’ follow up via a multidisciplinary approach. Every year its members gather to present and discuss the newest insights in the field in a meeting, and in this occasion virtually hosted from 18 to 22 of October (SEOM2021).

In this edition, MEDSIR took part with its trial DEBBRAH, designed, and sponsored by MEDSIR itself. The DEBBRAH design was recently presented at ESMO, and MEDSIR took advantage of this national congress to introduce the recruitment status of the 5 different cohorts of patients included in the study. Dr. Patricia Cortez, main author of the communication and medical oncologist at the IOB

Institute of Oncology in Madrid, presented the poster “Trastuzumab deruxtecan en pacientes con cáncer de mama metastásico HER2-positivo o con baja expresión de HER2 con metástasis cerebrales y/o carcinomatosis leptomeníngea: Estudio DEBBRAH”, ("Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive or low-HER2-expressing metastatic breast cancer with brain metastases and / or leptomeningeal carcinomatosis: DEBBRAH study") available online during the congress and on our website.


The single-arm, open label, phase II, trial DEBBRAH evaluates the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) in 5 different cohorts of pre-treated patients with Human Epidermal Growth Factor Receptor 2-Positive (HER2[+]) or HER2-low Advanced Breast Cancer (ABC), affected by brain metastases (BM) and/or leptomeningeal carcinomatosis (LMC). Patients with BM and LMC have limited therapeutic alternatives because they have traditionally been excluded from participation in most clinical trials evaluating systemic HER2-targeting regimens. DEBBRAH is currently enrolling a total of 39 patients across Spain and Portugal. Below, we provide details and recruitment status from each of the 5 cohorts:


· Cohort 1: HER2[+] BC with non-progressing BM (after stereotactic radiotherapy, whole-brain radiation therapy, or surgery). Recruitment Status: 8/8;

· Cohort 2: HER2[+] or HER2-low BC with asymptomatic untreated BM. Recruitment Status: 10/10;

· Cohort 3: HER2[+] BC with progressing BMs after local treatment. Recruitment Status: 9/7;

· Cohort 4: HER2-low expressing BC with progressing BMs after local treatment. Recruitment Status: 4/7

· Cohort 5: HER2[+] or HER2-low expressing BC with LMC. Recruitment Status: 4/7.


According to the recruitment status plan, the final patients will be recruited soon, and the primary outcomes from DEBBRAH should be available in early 2022.


Recent data on HER2[+] metastatic BC patients (DESTINY-Breast01, DESTINY-Breast03) showed good efficacy and a durable clinical activity of T-DXd, even in subgroups with asymptomatic BMs, representing a potential therapeutic opportunity also for those patients having centrals nervous system involvement.


In the light of these results, Dr. Cortez, main author of SEOM communication and medical oncologist at IOB Institute in Madrid, affirmed: “the oncological community is awaiting the outcome from the different cohorts in DEBBRAH with great interest. Our trial is pioneer in the context of BMC and LMC breast cancer patients, who have today very limited treatment options. If DEBBRAH confirms the efficacy of T-Dxd in these advanced and ultra-treated contexts, the drug could be introduced and administered to a large group of patients who are in need of valid and novel alternatives”.


Check out our poster at SEOM, and connect to the congress if you wish to receive more information:


DEBBRAH - Dr. Patricia Cortez

Poster #: ePoster-205

Trastuzumab deruxtecan (T-DXd; DS-8201) en pacientes con cáncer de mama metastásico HER2-positivo o con baja expresión de HER2 con metástasis cerebrales y/o carcinomatosis leptomeníngea:

Estudio DEBBRAH

[Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive or low-HER2-expressing metastatic breast cancer with brain metastases and / or leptomeningeal carcinomatosis: DEBBRAH study]

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