ClinicaliQ Trial Snapshot
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer — Recruiting • Phase I • Oncology • NCT03424005.
- What is being tested: An umbrella trial evaluating multiple treatment combination regimens across seven cohorts in patients with metastatic or inoperable locally advanced breast cancer, conducted in two sequential stages with adaptive design allowing cohort progression based on efficacy and safety data.
- Patient eligibility overview: The trial enrolls patients with confirmed metastatic breast cancer or locally advanced disease unsuitable for surgical resection, with detailed eligibility criteria applied per individual treatment cohorts during the two-stage evaluation process.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L…
Eligibility Snapshot
- Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort): * Age >/= 18 years at the time of signing Informed Consent Form * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Metastatic or inoperable locally advanced adenocarcinoma of the breast * Measurable disease (at least one target lesion) according to RECIST v1.1 * Life expectancy >/= 3 months, as determined by the investigator * Tumor accessible for biopsy, unless archival tissue is available * Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing * Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.