{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T02:47:14Z","timestamp":1791082034891,"version":"4.1.0"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T00:00:00Z","timestamp":1650931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T00:00:00Z","timestamp":1650931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer Res Treat"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This Phase 1\/2 study evaluated safety and efficacy of a topical submicron particle paclitaxel (SPP) in an anhydrous ointment base (SOR007), primarily in breast cancer patients with cutaneous metastases (CM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      One of three concentrations of SOR007 SPP (0.15%, 1.0%, or 2.0%) was applied twice daily over an area of 50\u00a0cm\n                      <jats:sup>2<\/jats:sup>\n                      under a 3\u2009+\u20093 phase\u00a01 design for up to 28\u00a0days, with the option for expansion to an additional 28\u00a0days at the highest dose\u00a0under a Phase 2a once safety was established. Efficacy was analyzed by lesion measurements and photographs to determine overall response rate (ORR), complete response (CR), and progression free survival by day 28 or 56.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty-three subjects were enrolled, 21 with cutaneous metastases of breast cancer (CMOBC). Four subjects received SOR007 0.15%\u00a0for a median of 28 days (range = 17\u201329), three at a dose of 1.0% for a median of 28\u00a0days (range\u2009=\u20096\u201329), and sixteen at 2.0% for a median of \u00a055\u00a0days (range\u2009=\u20096\u201360). All doses were well tolerated, and 19 subjects were evaluable for efficacy. At day 28 across all dose levels, 16% (95% CI 3.4 to 39.6%) of subjects achieved an ORR and another 63% (95% CI 34.9\u201396.8%) had stable disease (SD). The proportion of patients being progression free at 28\u00a0days across all treatments was 79% (95 CI 54\u201394%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Application of SOR007 0.15%, 1.0%, and 2.0% to CM was safe and well tolerated with some reduction in lesion pain, and minimal systemic absorption of paclitaxel. Lesion stabilization was observed in most subjects over the study period. A randomized, placebo-controlled trial to confirm these findings is warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov identifier<\/jats:title>\n                    <jats:p>NCT03101358.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-022-06584-6","type":"journal-article","created":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T04:02:56Z","timestamp":1650945776000},"page":"57-64","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Phase 1\/2 study of topical submicron particle paclitaxel for cutaneous metastases of breast cancer"],"prefix":"10.1007","volume":"194","clinical-trial-number":[{"clinical-trial-number":"nct03101358","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Mario E.","family":"Lacouture","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shari B.","family":"Goldfarb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Markova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sant P.","family":"Chawla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karan","family":"Dewnani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9959-3763","authenticated-orcid":false,"given":"Marc","family":"Iacobucci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie E.","family":"Lang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,4,26]]},"reference":[{"key":"6584_CR1","doi-asserted-by":"publisher","first-page":"3144","DOI":"10.1200\/JCO.2014.55.4634","volume":"32","author":"DE Spratt","year":"2014","unstructured":"Spratt DE, Gordon Spratt EA, Wu S, DeRosa A, Lee NY, Lacouture ME, Barker CA (2014) Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis. 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