Evidence map›Paper›PMID 31849532›Full record

ArticleCancer management and research2019

First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial.

Minetta C Liu, Wolfgang Janni, Vassilis Georgoulias, Denise A Yardley, Nadia Harbeck, Xin Wei, Desmond McGovern, Robert Beck

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancer management and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01881230 (A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.4field-weighted citation impact, top 33% 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.

NCT01881230 phase2 / phase3completednot on this map

A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

TypeinterventionalSponsorCelgeneRan2013 to 2016Enrolled191ConditionsBreast Tumor, Breast Cancer, Cancer of the Breast, Estrogen Receptor- Negative Breast CancerArmsnab-Paclitaxel, Carboplatin, Gemcitabine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 12 citations in OpenAlex.

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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

8 authors at 4 institutions in 3 countries.

Minetta C LiuDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Wolfgang JanniDepartment of Obstetrics and Gynecology, University Clinic Ulm, Ulm, Germany.
Vassilis GeorgouliasDepartment of Medical Oncology, School of Medicine, University of Crete, Crete, Greece.
Denise A YardleyDepartment of Medical Oncology, Breast Cancer Research Program, Sarah Cannon Research Institute, Nashville, TN, USA.
Nadia HarbeckDepartment of Breast Center, Oncological Therapy and Clinical Trials Unit, University of Munich (LMU), Munich, Germany.ORCID 0000-0002-9744-7372
Xin WeiDepartment of Translational/Clinical Development, Celgene Corporation, Summit, NJ, USA.
Desmond McGovernDepartment of Clinical Research, Celgene Corporation, Summit, NJ, USA.
Robert BeckDepartment of Clinical Research, Celgene Corporation, Summit, NJ, USA.ORCID 0000-0002-1934-9320
Ludwig-Maximilians-Universität München · DEMayo Clinic in Arizona · USSarah Cannon · USUniversity of Crete · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCirculating tumor cells (CTCs) are prognostic biomarkers in metastatic breast cancer, but their role in predicting treatment outcomes in metastatic triple-negative breast cancer (mTNBC) is less clear. The tnAcity trial demonstrated a significant progression-free survival (PFS) benefit with

methodsCTC enumeration, performed using CELLSEARCH technology (Menarini Silicon Biosystems, Huntingdon Valley, PA, USA), was a prespecified exploratory endpoint in the tnAcity trial. Patients with TNBC were categorized based on pre- and post-treatment CTC levels: Group 1 (+ + +; elevated CTCs at baseline and postbaseline), Group 2 (+ ± ±; CTCs elevated at baseline and cleared postbaseline [cycle 3 and/or cycle 5]), or Group 3 (-; no CTCs detected at baseline). The baseline cutoff was ≥1 CTC/7.5 mL for the main analysis; cutoffs of ≥2 and ≥5 CTCs were used for supporting analyses.

resultsThe main analysis included 126 patients (Group 1, n = 24; Group 2, n = 54; and Group 3, n = 48). The median PFS was longer in Group 2 vs Group 1 (8.5 vs 4.7 months; HR, 0.30 [95% CI, 0.17-0.54]). These results were supported by the ≥2- and ≥5-CTC cutoff analyses. The median overall survival rates were 17.8, 16.0, and 9.8 months in Groups 2, 3, and 1, respectively. The overall response rates were 79.6%, 43.8%, and 29.2%, respectively. A numerically higher percentage of patients had CTC clearance during

conclusionEfficacy outcomes trended positively with chemotherapy-induced elimination of CTCs, suggesting that CTC clearance may predict the chemosensitivity of mTNBC tumors.

trial registrationEudraCT Number: 2013-000113-20; ClinicalTrials.gov number: NCT01881230.

Indexed as

chemotherapycirculating tumor cellsmetastatic triple-negative breast cancernab-paclitaxelprognosis

Identifiers

PMID31849532
PMCPMC6913260
OpenAlexW2995370798

What OpenQuestion holds

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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.