Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative

Summary

This phase II trial studies how well pegylated liposomal doxorubicin, bevacizumab, and everolimus work in treating patients with triple-negative breast cancer with tumors predicted insensitive to standard chemotherapy. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin, work in different ways to stop the growth of tumor cells by stopping them from dividing. Bevacizumab may stop or slow breast cancer by blocking the growth of new blood vessels necessary for tumor growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pegylated liposomal doxorubicin together with bevacizumab and everolimus may kill more tumor cells.

Timeline

Start

2016-01-12

Primary completion

2023-05-24

Completion

2023-05-24

Outcome

Missed primary endpoint

paper None of the study participants experienced a pCR. PMID 37043123 ↗

paper Among all 17 patients, 6%, 76%, and 18%, were found to have RCB-I, RCB-II, and RCB-III disease, respectively. PMID 37043123 ↗

paper Neoadjuvant DAT/DAE failed to demonstrate meaningful clinical activity in patients with mesenchymal and/or metaplastic TNBC following suboptimal response to neoadjuvant AC. PMID 37043123 ↗

Publications

• Abuhadra N, Sun R, Bassett RL Jr, Huo L, Chang JT, Teshome M, Clayborn AR, White JB, Ravenberg EE, Adrada BE, Candelaria RP, Yang W, Ding Q, Symmans WF, Arun B, Damodaran S, Koenig KB, Layman RM, Lim B, Litton JK, Thompson A, Ueno NT, Piwnica-Worms H, Hortobagyi GN, Valero V, Tripathy D, Rauch GM, Moulder S, Yam C. Targeting chemotherapy resistance in mesenchymal triple-negative breast cancer: a phase II trial of neoadjuvant angiogenic and mTOR inhibition with chemotherapy. Invest New Drugs. 2023 Jun;41(3):391-401. doi: 10.1007/s10637-023-01357-4. Epub 2023 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Doxorubicin	Other / unclassified	30 mg/m2	Intravenous
Subject	Everolimus	Small molecule	7.5 mg	Oral

Indications