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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Multiple Cancer Types

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, six 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 treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-nave cohort).

Cohort 3, 5, and 6 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.

Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).

In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-nave cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Breast, Phase I
I/II
Kennedy, Laura
NCT03424005
VICCBREP2126

A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

Phase I

Phase I
I
Berlin, Jordan
NCT05382559
VICCPHI2207

A Randomized Clinical Trial Comparing ctDNA-directed Therapy Change with Standard of Care in Patients with Metastatic Triple Negative Breast Cancer

Breast

Breast
II
Abramson, Vandana
NCT05770531
VICCBRE2257

A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors

Multiple Cancer Types

Colon, Esophageal, Gastric/Gastroesophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic, Phase I, Rectal, Uterine
I
Cardin, Dana
NCT06586515
VICC-DTGIT24002P