Evidence map›Paper›PMID 28547525›Full record

Trial reportInternational journal of clinical oncology2017

Neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin administered every 3 weeks for Japanese women with HER2-positive primary breast cancer: efficacy and safety.

Ikuko Sugitani, Shigeto Ueda, Takashi Sakurai, Takashi Shigekawa, Eiko Hirokawa, Hiroko Shimada, Hideki Takeuchi, Kazuo Matsuura, Misono Misumi, Nobuko Fujiuchi and 4 more

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

Trial report in International journal of clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03989037 (A Phase III, Randomized, Single-blind Study Comparing the Efficacy, Safety, and Immunogenicity of SIBP-01 and CN-Trastuzumab Combination With Docetaxel and Carboplatin in Patients With Early or Locally Advanced Her2 Positive Breast Cancer), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 42% 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.

NCT03989037 phase3completednot on this mapstarted 2019, after this paper: background citation

A Phase III, Randomized, Single-blind Study Comparing the Efficacy, Safety, and Immunogenicity of SIBP-01 and CN-Trastuzumab Combination With Docetaxel and Carboplatin in Patients With Early or Locally Advanced Her2 Positive Breast Cancer

TypeinterventionalSponsorShanghai Institute Of Biological ProductsRan2019 to 2023Enrolled580ConditionsHER2-positive Early Breast CancerArmsSIBP-01, Herceptin, Docetaxel, Carboplatin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Neoadjuvant therapy withAnnals of translational medicine · 2023
    Article
  5. Article
  6. 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

14 authors at 3 institutions in 1 country.

Ikuko SugitaniDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Shigeto UedaDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Takashi SakuraiBreast Center, JCHO Saitama Medical Center, 4-9-3, Kita-urawa, Urawa-ku, Saitama, 330-0074, Japan.
Takashi ShigekawaDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Eiko HirokawaDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Hiroko ShimadaDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Hideki TakeuchiDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Kazuo MatsuuraDepartment of Breast Surgery, Hiroshima Prefectural Hospital, 1-5-54 Kanda, Minami-ku, Hiroshkloima-Shi, Hiroshima, 734-8530, Japan.
Misono MisumiDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Nobuko FujiuchiDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Takao TakahashiDepartment of Palliative Medicine, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, Japan, 350-1298.
Takahiro HasebeDepartment of Pathology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Akihiko OsakiDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. tsaeki@saitama-med.ac.jp.
Saitama Medical University · JPHiroshima Prefectural Hospital · JPSocial Insurance Saitama Chuo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase II neoadjuvant study evaluated the efficacy and safety of a triweekly regimen of docetaxel and carboplatin in combination with trastuzumab (TCbH) in Japanese women with human epidermal growth factor receptor type2 (HER2)-positive primary breast cancer.

methodsPatients with HER2-positive, stage I-III invasive breast cancer received six courses of trastuzumab (8 mg/kg loading dose, then 6 mg/kg, day 1), docetaxel (75 mg/m

resultsFifty patients were enrolled in this study. Median age was 58 (range 32-75) years. All patients underwent definitive surgery. Thirty-three (66%) patients completed the chemotherapy course, while the treatment was delayed or discontinued in the other 17 (34%) patients because of adverse events (AEs). The pCR rate was 52%; the overall response rate was 66%. Grade 3/4 AEs due to nonhematological toxicity were anorexia (4%), diarrhea (2%), and rash (2%), and those due to hematological toxicity were neutropenia (36%), anemia (12%), and thrombocytopenia (2%).

conclusionAlthough the triweekly six-course regimen of TCbH achieved a high pCR rate, hematological AEs frequently occurred during the latter part of the chemotherapy course. One-third of patients experienced delayed or discontinued chemotherapy. Clinical registration number: http://www.umin.org.au UMIN000013513.

Indexed as

AdultAgedAnorexiaAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleBreast NeoplasmsCarboplatinDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoadjuvant TherapyNeutropeniaTaxoidsTrastuzumabCarboplatinDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTaxoidsTrastuzumabBreast cancerCarboplatinDocetaxelNeoadjuvant chemotherapyTrastuzumab

Identifiers

PMID28547525
PMCPMC5608788
OpenAlexW2618162959

What OpenQuestion holds

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LicenceCC BY
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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.