Evidence map›Paper›PMID 34554370›Full record

Trial reportBreast cancer research and treatment2021

A phase II study of sequential treatment with anthracycline and taxane followed by eribulin in patients with HER2-negative, locally advanced breast cancer (JBCRG-17).

Ippei Fukada, Yoshinori Ito, Naoto Kondo, Shoichiro Ohtani, Masaya Hattori, Eriko Tokunaga, Nobuki Matsunami, Kohjiro Mashino, Taijiro Kosaka, Masahiko Tanabe and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

20 authors.

Ippei FukadaDepartment of Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. ippei.fukada@jfcr.or.jp.ORCID http://orcid.org/0000-0001-7272-3708
Yoshinori ItoDepartment of Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Naoto KondoDepartment of Breast Surgery, Nagoya City University Hospital, Nagoya, Aichi, Japan.
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Masaya HattoriDepartment of Breast Oncology, Aichi Cancer Center, Nagoya, Aichi, Japan.
Eriko TokunagaDepartment of Breast Oncology, National Kyusyu Cancer Center, Fukuoka, Japan.
Nobuki MatsunamiDepartment of Breast Surgery, Osaka Rosai Hospital, Osaka, Japan.
Kohjiro MashinoDepartment of Surgery, Oita Prefectural Hospital, Oita, Japan.
Taijiro KosakaDepartment of Breast Surgery, Juntendo University Nerima Hospital, Tokyo, Japan.
Masahiko TanabeDepartment of Breast Oncology, Juntendo University Hospital, Tokyo, Japan.
Daisuke YotsumotoDepartment of Breast Surgery, Social Medical Corporation Hakuaikai, Sagara Hospital, Kagoshima, Japan.
Kosho YamanouchiDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Masataka SawakiDepartment of Breast Oncology, Aichi Cancer Center, Nagoya, Aichi, Japan.
Masahiro KashiwabaDepartment of Breast Oncology, Breastopia Miyazaki Hospital, Miyazaki, Japan.
Hidetaka KawabataDepartment of Breast and Endocrine Surgery, Toranomon Hospital, Tokyo, Japan.
Katsumasa KuroiDepartment of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shinji OhnoBreast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Masakazu ToiBreast Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.ORCID http://orcid.org/0000-0002-7302-0278

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe sequence of taxanes (T) followed by anthracyclines (A) as neoadjuvant chemotherapy has been the standard of care for almost 20 years for locally advanced breast cancer (LABC). Sequential administration of eribulin (E) following A/T could provide a greater response rate for women with LABC.

methodsIn this single-arm, multicenter, Phase II prospective study, the patients received 4 cycles of the FEC regimen and 4 cycles of taxane. After the A/T-regimen, 4 cycles of E were administered followed by surgical resection. The primary endpoint was the clinical response rate. Eligible patients were women aged 20 years or older, with histologically confirmed invasive breast cancer, clinical Stage IIIA (T2-3 and N2 only), Stage IIIB, and Stage IIIC, HER2-negative.

resultsA preplanned interim analysis aimed to validate the trial assumptions was conducted after treatment of 20 patients and demonstrated that clinical progressive disease rates in the E phase were significantly higher (30%) than assumed. Therefore, the Independent Data Monitoring Committee recommended stopping the study. Finally, 53 patients were enrolled, and 26 patients received the A/T/E-regimen. The overall observed clinical response rate (RR) was 73% (19/26); RRs were 77% (20/26) in the AT phase and 23% (6/26) in the E phase. Thirty percent (8/26) of patients had PD in the E phase, 6 of whom had achieved cCR/PR in the AT phase. Reported grade ≥ 3 AEs related to E were neutropenia (42%), white blood cell count decrease (27%), febrile neutropenia (7.6%), weight gain (3.8%), and weight loss (3.8%).

conclusionSequential administration of eribulin after the A/T-regimen provided no additional effect for LABC patients. Future research should continue to focus on identifying specific molecular biomarkers that can improve response rates.

Indexed as

AnthracyclinesBreast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBridged-Ring CompoundsErb-b2 Receptor Tyrosine KinasesFemaleFuransHumansKetonesNeoadjuvant TherapyPolyether PolyketidesProspective StudiesTaxoidsTreatment OutcomeAnthracyclinesBridged-Ring CompoundsErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonesPolyether PolyketidestaxaneTaxoidsEribulinHER2-negativeLocally advanced breast cancerNeoadjuvant chemotherapySequential therapy

Identifiers

PMID34554370
PMCPMC8558278

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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.