{"doi":"10.1093/oncolo/oyad026","title":"Phase I Trial of Ipatasertib Plus Carboplatin, Carboplatin/Paclitaxel, or Capecitabine and Atezolizumab in Metastatic Triple-Negative Breast Cancer","abstract":"BACKGROUND: This trial evaluated the safety and efficacy of ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab in patients with metastatic triple-negative breast cancer (mTNBC). METHODS: Eligibility criteria were mTNBC, RECIST 1.1 measurable disease, no prior use of platinum for metastatic disease (Arms A and B), and no prior exposure to immune checkpoint inhibitor (Arm C). Primary endpoints were safety and RP2D. Secondary endpoints were progression-free survival (PFS), response rate, and overall survival. RESULTS: RP2D for Arm A (n = 10) was ipatasertib 300 mg daily, carboplatin AUC2, and paclitaxel 80 mg m-2 days 1, 8, and 15 every 28 days. RP2D for Arm B (n = 12) was ipatasertib 400 mg daily and carboplatin AUC2 days 1, 8, and 15 every 28 days. RP2D for Arm C (n = 6) was likely ipatasertib 300 mg 21 days on 7 days off, capecitabine 750 mg m-2, twice a day, 7 days on 7 days off, and atezolizumab 840 mg days 1 and 15 every 28 days. The most common (≥10%) grade 3-4 AEs at RP2D for Arm A (N = 7 at RP2D) were neutropenia (29%), diarrhea (14%), oral mucositis (14%), and neuropathy (14%); Arm B had diarrhea (17%) and lymphopenia (25%); and Arm C had anemia, fatigue, cognitive disturbance, and maculopapular rash (17% each). Overall responses at RP2D were 29% Arm A, 25% Arm B, and 33% Arm C. PFS was 4.8, 3.9, and 8.2 months for patients on Arms A, B, and C, respectively. CONCLUSIONS: Continuous dosing of ipatasertib with chemotherapy was safe and well-tolerated. Further study is warranted in understanding the role of AKT inhibition in treatment of TNBCs. TRIAL REGISTRATION: NCT03853707.","journal":"The Oncologist","year":2023,"id":342520,"datarank":0.5799368313023687,"base_score":2.70805020110221,"endowment":2.70805020110221,"self_citation_contribution":0.40620753016533157,"citation_network_contribution":0.17372930113703722,"self_endowment_contribution":0.40620753016533157,"citer_contribution":0.17372930113703722,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"citer_count":14,"citers_with_citation_signal":9,"citers_with_endowment":9,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9427,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03853707"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":461448,"name":"Susan E. Yost","orcid":"0000-0002-9422-0316","position":1,"is_corresponding":false},{"id":1061758,"name":"Yujie Cui","orcid":"0000-0001-9466-9853","position":2,"is_corresponding":false},{"id":461449,"name":"Christopher Ruel","orcid":"0000-0002-7205-0803","position":3,"is_corresponding":false},{"id":923039,"name":"Mireya Murga","orcid":null,"position":4,"is_corresponding":false},{"id":462559,"name":"Aileen Tang","orcid":null,"position":5,"is_corresponding":false},{"id":462560,"name":"Norma Martínez","orcid":null,"position":6,"is_corresponding":false},{"id":462558,"name":"Daniel Schmolze","orcid":null,"position":7,"is_corresponding":false},{"id":294149,"name":"James Waisman","orcid":"0000-0003-2896-4146","position":8,"is_corresponding":false},{"id":992881,"name":"Niki Patel","orcid":null,"position":9,"is_corresponding":false},{"id":449642,"name":"Lalitkumar K. Vora","orcid":"0000-0001-8106-9066","position":10,"is_corresponding":false},{"id":474073,"name":"Lusine Tumyan","orcid":null,"position":11,"is_corresponding":false},{"id":1079475,"name":"Mari Bozoghlanian","orcid":null,"position":12,"is_corresponding":false},{"id":461451,"name":"Daphne Stewart","orcid":"0000-0001-9845-8375","position":13,"is_corresponding":false},{"id":380347,"name":"Paul Frankel","orcid":"0000-0003-2231-6121","position":14,"is_corresponding":false},{"id":443405,"name":"Yuan Yuan","orcid":"0000-0001-7440-8939","position":0,"is_corresponding":true}],"reference_count":46,"raw_metadata":null,"created_at":"2026-07-19T01:11:12.506815Z","pmid":"37023705","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}