Evidence map›Paper›PMID 39928262›Full record

Trial reportBreast cancer research and treatment2025

A randomized phase II trial of nab-paclitaxel with or without mifepristone for advanced triple-negative breast cancer.

Nan Chen, Margarite Matossian, Poornima Saha, Murtuza Rampurwala, Salaija Kamaraju, Olwen Hahn, Frederick M Howard, Gini F Fleming, Jincong Q Freeman, Theodore Karrison and 3 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
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

13 authors.

Nan ChenDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Margarite MatossianDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Poornima SahaDepartment of Medicine, NorthShore University Health System, Evanston, IL, USA.
Murtuza RampurwalaDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Salaija KamarajuDepartment of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
Olwen HahnDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Frederick M HowardDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Gini F FlemingDepartment of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Jincong Q FreemanDepartment of Public Health, University of Chicago, Chicago, IL, USA.
Theodore KarrisonDepartment of Biostatistics, University of Chicago, Chicago, IL, USA.
Suzanne ConzenDepartment of Medicine Section of Hematology/Oncology, University of Texas Southwestern, Dallas, TX, USA.
Rita Nanda *Department of Medicine Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA. rnanda@bsd.uchicago.edu.
Erica M Stringer-Reasor *Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. esreasor@uabmc.edu.

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI KUNLE ODUNSI · 1985 to 2026
$122.1M
BASIC RESEARCH TRAINING IN MEDICAL ONCOLOGYT32CA009566 · NCI · UNIVERSITY OF CHICAGO · PI OLUFUNMILAYO F. OLOPADE · 1987 to 2026
$10.5M
CLINICAL THERAPEUTICST32GM007019 · NIGMS · UNIVERSITY OF CHICAGO · PI Peter Hugh O'Donnell, MARK J RATAIN · 1985 to 2026
$8.7M
SPECIALIZED TRAINING PROGRAM IN THE DEMOGRAPHY &ECON.T32AG000243 · NIA · UNIVERSITY OF CHICAGO · PI DAVID O MELTZER · 1994 to 2026
$8.2M
Integrating Clinical, Pathologic, and Immune Features to Predict Breast Cancer Recurrence and Chemotherapy BenefitK08CA283261 · NCI · UNIVERSITY OF CHICAGO · PI Frederick Matthew Howard · 2023 to 2026
$806k
NCI NIH HHS K08 CA283261NCI NIH HHS K08CA283261NCI NIH HHS P30 CA014599NCI NIH HHS T32 CA009566NIA NIH HHS T32 AG000243NIA NIH HHS T32AG000243NIGMS NIH HHS T32 GM007019NIH HHS T32GM007019
6 · The paper itself

Abstract

purposeGlucocorticoid receptor (GR) activity may mediate chemoresistance in advanced triple-negative breast cancer (TNBC). Preclinical studies demonstrate that GR antagonism can augment the effect of taxanes in TNBC models. We hypothesized that pretreatment with mifepristone, a potent GR antagonist, would enhance nab-paclitaxel efficacy in advanced TNBC.

methodsThis trial was terminated early due to poor accrual. 29 of 64 planned patients were enrolled. Patients were randomized to receive nab-paclitaxel with or without mifepristone; oral mifepristone 300 mg was administered the day prior and day of each dose of nab-paclitaxel. The primary endpoint was progression-free survival (PFS); secondary/exploratory endpoints included response rate and correlation of response with GR expression.

resultsThe addition of mifepristone to nab-paclitaxel did not improve PFS (3.0 m vs 3.0 m, p = 0.687) or overall response rate (23% vs 31.5%) compared to nab-paclitaxel alone. There was a trend towards improved overall survival in the combination group, primarily driven by one long-term responder. Increased rates of grade 3 neutropenia (46% vs 7%) and febrile neutropenia were observed in the combination arm, while other toxicities were similar in both groups. Increased GR expression was not correlated with clinical response in the combination arm.

conclusionsWhile there were responders to the combination, the study was underpowered to meet the primary endpoint. Higher rates of neutropenia were observed in the combination, but overall it was well tolerated. Preclinical data in TNBC and clinical data in other malignancies support further investigation of GR modulators. Future studies should incorporate biomarkers to select patients who benefit from GR inhibition.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsTriple Negative Breast NeoplasmsAdultAgedAlbuminsFemaleHumansMiddle AgedMifepristoneNeoplasm StagingPaclitaxelReceptors, GlucocorticoidTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsMifepristonePaclitaxelReceptors, GlucocorticoidClinical trialGlucocorticoid receptorHER2- breast cancerMifepristoneNab-paclitaxel

Identifiers

PMID39928262
PMCPMC11952973

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Registered trials

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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.