Evidence map›Paper›PMID 34476645›Full record

Trial reportBreast cancer research and treatment2021

A randomized, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for metastatic triple-negative breast cancer (fRida).

Lori J Goldstein, Mauro Mansutti, Christelle Levy, Jenny C Chang, Stephanie Henry, Isaura Fernandez-Perez, Jana Prausovà, Elzbieta Staroslawska, Giuseppe Viale, Beth Butler and 5 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 1% 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.

NCT01861054 phase2terminatednot on this map

A Single Arm, Preoperative, Pilot Study to Evaluate the Safety and Biological Effects of Orally Administered Reparixin in Early Breast Cancer Patients Who Are Candidates for Surgery

TypeinterventionalSponsorDompé Farmaceutici S.p.ARan2013 to 2016Enrolled20ConditionsBreast CancerArmsReparixin
NCT02370238 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)

TypeinterventionalSponsorDompé Farmaceutici S.p.ARan2015 to 2020Enrolled194ConditionsMetastatic Breast CancerArmspaclitaxel, Reparixin, placebo
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
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  11. Article
  12. Protein Marker-Dependent Drug Discovery Targeting Breast Cancer Stem Cells.International journal of molecular sciences · 2025
    Review
  13. Target neutrophil heterogeneity and plasticity in cancer.Journal of hematology & oncology · 2025
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Harnessing myeloid cells in cancer.Molecular cancer · 2025
    Review
  19. Review
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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

15 authors at 10 institutions in 7 countries.

Lori J GoldsteinDepartment of Medical Oncology, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA, 19111, USA. Lori.Goldstein@fccc.edu.ORCID http://orcid.org/0000-0002-6542-3421
Mauro MansuttiAzienda Ospedaliero Universitaria Santa Maria della Misericordia, 33100, Udine, Italy.
Christelle LevyCLCC Francois Baclesse, Caen, France.
Jenny C ChangThe Methodist Hospital Research Institute, Houston, Tx, 77030, USA.
Stephanie HenryCHU UCL Namur, site Ste Elisabeth, Namur, Belgium.
Isaura Fernandez-PerezHospital Alvaro Cunqueiro, 36204, Vigo, Spain.
Jana PrausovàFakultni nemocnice v Motole, Onkologická klinika 2, LF UK a FN Motol, Praha, Czech Republic.
Elzbieta StaroslawskaCentrum Onkologii Ziemi Lubelskiej św. Jana z Dukli, Lublin, Poland.
Giuseppe VialeIEO Istituto Europeo di Oncologia IRCCS, 20141, Milano, Italy.
Beth ButlerResearch and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy.
Susan McCannaResearch and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy.
Pier Adelchi RuffiniResearch and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy.
Max S WichaRogel Cancer Center, University of Michigan, Ann Arbor, MI, 48109, USA.
Anne F SchottRogel Cancer Center, University of Michigan, Ann Arbor, MI, 48109, USA.
fRida Trial Investigators
University of Michigan · USDompé (Italy) · ITCentre François Baclesse · FRCHU Dinant Godinne UCL Namur · BEFox Chase Cancer Center · USHouston Methodist · USLublin Oncology Center · PLUniversity Hospital Complex Of Vigo · ESUniversity Hospital in Motol · CZUniversity of Milan · IT

Funding

WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Dietmar J Kappes · 1985 to 2026
$138.8M
NCI NIH HHS P30 CA006927
6 · The paper itself

Abstract

purposeCXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC. SUBJECTS AND

methodsSubjects with untreated mTNBC were randomized 1:1 to R or placebo days 1-21 in combination with weekly P 80 mg/m

results123 subjects were randomized (62 to R + P and 61 to placebo + P). PFS was not different between the 2 groups (median 5.5 and 5.6 months for R + P and placebo + P, respectively; HR 1.13, p = 0.5996). ALDH

conclusionfRida is the first randomized, double-blind clinical trial of a CSC-targeting agent in combination with chemotherapy in breast cancer. The primary endpoint of prolonged PFS was not met. CLINICAL TRIAL REGISTRATION/DATE OF REGISTRATION: NCT01861054/February 24, 2015.

Indexed as

Triple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansPaclitaxelSulfonamidesPaclitaxelreparixinSulfonamidesCancer stem cellsCXCR1ReparixinTNBC

Identifiers

PMID34476645
PMCPMC8558154
OpenAlexW3196480782

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.