OncoMatch/Clinical Trials/NCT03424005
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Is NCT03424005 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for metastatic breast cancer.
Treatment: Capecitabine · Atezolizumab · Ipatasertib · SGN-LIV1A · Bevacizumab · Chemotherapy (Gemcitabine + Carboplatin or Eribulin) · Selicrelumab · Tocilizumab · Nab-Paclitaxel · Sacituzumab Govitecan · Abemaciclib · Fulvestrant · Ribociclib (Dose #1) · Inavolisib (Dose #1) · Trastuzumab Deruxtecan · Ribociclib (Dose #2) · Letrozole · Inavolisib (Dose #2) · Inavolisib · Empagliflozin · Palbociclib · Metformin · Atirmociclib — 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-naïve 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-naïve 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: T-cell co-stimulating or immune checkpoint blockade therapies (anti-CTLA-4, anti-PD-1, anti-PD-L1, CD40 agonists, interleukin-2 (IL-2), IL-2-like compounds)
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
Cannot have received: biologic treatment (bevacizumab)
Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment
Cannot have received: systemic treatment for TNBC
other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor alpha agents)
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Cannot have received: investigational therapy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Lab requirements
Blood counts
Adequate hematologic function, defined by laboratory test results, obtained within 14 days prior to initiation of study treatment
Kidney function
Adequate end-organ function, defined by laboratory test results, obtained within 14 days prior to initiation of study treatment
Liver function
Adequate end-organ function, defined by laboratory test results, obtained within 14 days prior to initiation of study treatment
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- University of California San Diego Medical Center · La Jolla, California
- Stanford Cancer Institute · Stanford, California
- Rocky Mountain Cancer Center - Longmont · Longmont, Colorado
- H. Lee Moffitt Cancer Center and Research Inst. · Tampa, Florida
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