Evidence map›Paper›PMID 35471470›Full record

Trial reportBreast cancer research and treatment2022

Phase 1/2 study of topical submicron particle paclitaxel for cutaneous metastases of breast cancer.

Mario E Lacouture, Shari B Goldfarb, Alina Markova, Sant P Chawla, Karan Dewnani, Marc Iacobucci, Julie E Lang

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research and treatment, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03101358 (Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03101358 phase1 / phase2completednot on this map

Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases

TypeinterventionalSponsorNanOlogy, LLCRan2018 to 2020Enrolled23ConditionsCutaneous MetastasisArmsSOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Mario E LacoutureMemorial Sloan Kettering Cancer Center, New York, NY, 10065, USA. lacoutum@mskcc.org.
Shari B GoldfarbMemorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.
Alina MarkovaMemorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.
Sant P ChawlaSarcoma Oncology Center, Santa Monica, CA, 90403, USA.
Karan DewnaniNanOlogy, LLC, Fort Worth, TX, 76107, USA.
Marc IacobucciNanOlogy, LLC, Fort Worth, TX, 76107, USA.ORCID http://orcid.org/0000-0001-9959-3763
Julie E LangUniversity of Southern California Keck School of Medicine, Los Angeles, CA, 90033, USA.
Memorial Sloan Kettering Cancer Center · USSarcoma Oncology Center · USUniversity of Southern California · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThis 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).

methodsOne of three concentrations of SOR007 SPP (0.15%, 1.0%, or 2.0%) was applied twice daily over an area of 50 cm

resultsTwenty-three subjects were enrolled, 21 with cutaneous metastases of breast cancer (CMOBC). Four subjects received SOR007 0.15% for a median of 28 days (range = 17-29), three at a dose of 1.0% for a median of 28 days (range = 6-29), and sixteen at 2.0% for a median of  55 days (range = 6-60). 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 34.9-96.8%) had stable disease (SD). The proportion of patients being progression free at 28 days across all treatments was 79% (95 CI 54-94%).

conclusionApplication 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. CLINICALTRIALS: GOV IDENTIFIER: NCT03101358.

Indexed as

Breast NeoplasmsPaclitaxelSkin NeoplasmsFemaleHumansProgression-Free SurvivalTreatment OutcomePaclitaxelBreast cancerClinical trialCutaneous metastasesPaclitaxelSOR007Submicron particle paclitaxel

Identifiers

PMID35471470
PMCPMC9167189
OpenAlexW4226318573

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.