Clinical trial NCT06504719: Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan
Official title: Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients With Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Metastatic Cancer
Keywords: Trastuzumab deruxtecan
Sacituzumab govitecan
Efficacy
Safety
Brain metastasis
ILD
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients with histologically confirmed metastatic/recurrent breast cancer. Patients need to have received treatment with T-DXd and/or SG at Departments of Oncology in Departments of Oncology associated with the Hellenic Cooperative Oncology Group (HeCOG). Eligible patients are 18 years or older, diagnosed with triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer, who received an ADC at any of line of treatment. Patients who received at least one cycle of T-DXd and/or SG are included. Immunohistochemical markers may be determined locally. Treatment with T-DXd and SG is administered per national guidelines.

Brief summary: The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.

Detailed description: Antibody-drug conjugates (ADCs) have significantly changed the therapeutic landscape of advanced breast cancer. Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. The study aims to evaluate real-world efficacy and toxicity data of treatment with T-DXd and SG in pretreated patients with advanced breast cancer.

This study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with T-DXd and SG at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic/recurrent breast cancer
* 18 years of age
* Triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer
* Treatment with an ADC at any of line of treatment
* Treatment with at least one cycle of T-DXd and/or SG

Exclusion Criteria:

* NA

Primary outcomes:
measure: The primary endpoint was toxicity rate of each drug
timeFrame: From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Cooperative Oncology Group
Study officials:
References: