Clinical trial NCT04257162: HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Official title: HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: SOLTI Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2020-02-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected.


Eligibility criteria: A. Inclusion Criteria

1. Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a).
2. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart.
3. Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer.
4. Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content.

   1. Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases.
   2. Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
5. Patients included before starting experimental treatment must be able and willing to provide blood sample(s).

   B. Exclusion Criteria
6. Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan.
7. Inability to comply with study and follow-up procedures

Primary outcomes:
measure: identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: ICO Badalona
state: Barcelona
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez
state: Cadiz
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Islas Canarias
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Barcelona
country: Spain
facility: ICO Hospitalet
city: Lleida
country: Spain
facility: H.Univ. Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Virgen de Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología (IVO)
Study officials:
References: