Evidence map›Paper›PMID 32019278›Full record

Trial reportCancer research and treatment2020

PIK3CA H1047R Mutation Associated with a Lower Pathological Complete Response Rate in Triple-Negative Breast Cancer Patients Treated with Anthracycline-Taxane-Based Neoadjuvant Chemotherapy.

Sanxing Guo, Sibylle Loibl, Gunter von Minckwitz, Silvia Darb-Esfahani, Bianca Lederer, Carsten Denkert

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01426880 (A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT01426880 phase2 / phase3completednot on this map

A Randomized Phase II Trial Investigating the Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer

TypeinterventionalSponsorGBG Forschungs GmbHRan2011 to 2013Enrolled595ConditionsTubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast CancerArmsCarboplatin, background treatment
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Platinum-based chemotherapy for early triple-negative breast cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
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  6. Review
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  10. Hormone Receptor Positive/HER2 Negative Breast Carcinoma: Association ofInternational journal of molecular sciences · 2025
    Article
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  12. International journal of molecular sciences · 2025
    Review
  13. Review
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  15. Review
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  19. Prevalence and effect ofSaudi journal of biological sciences · 2024
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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

6 authors at 2 institutions in 2 countries.

Sanxing GuoDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Sibylle LoiblGerman Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.
Gunter von MinckwitzGerman Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.
Silvia Darb-EsfahaniInstitute of Pathology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Bianca LedererGerman Breast Group, Neu-Isenburg, Charité Universitätsmedizin Berlin, Berlin, Germany.
Carsten DenkertInstitute of Pathology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Charité - Universitätsmedizin Berlin · DEGerman Breast group · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePIK3CA, encoding for subunit p110a of phosphatidylinositol 3 kinase, is frequently mutated in breast cancer. PIK3CA mutation was predictive for pathological complete response (pCR) in human epidermal growth factor 2 positive breast cancer. This study explores the association of PIK3CA mutation and pCR in triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy. MATERIALS AND

methodsA total of 92 patients with TNBC derived from a prospectively randomized phase II trial GeparSixto study (NCT01426880). Exon 9 and exon 20 of PIK3CA mutations were evaluated by using classical Sanger method with formalin-fixed paraffin-embedded tumor tissues.

resultsSeven of 90 tumors (7.8%) were detectable with a PIK3CA H1047R mutation. Overall, PIK3CA H1047R mutation was significantly associated with a lower pCR rate (14.3% vs. 56.6%; odds ratio, 0.128; 95% confidence interval [CI], 0.015 to 1.108; p=0.047). In carboplatin- containing treatment patients, H1047R mutation trended to predict a lower pCR rate (20% vs. 62.5%; p=0.146). In a multivariable analysis, H1047R mutation trended to predict a lower pCR rate (hazard ratio, 0.1; 95% CI, 0.01 to 1; p=0.056).

conclusionTNBC with a PIK3CA H1047R mutation was less likely to achieve pCR after anthracycline-based neoadjuvant chemotherapy. Development of H1047R mutant selective inhibitors might be helpful to conquer this subtype of breast cancer.

Indexed as

MutationNeoadjuvant TherapyAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCarboplatinCarcinoma, Ductal, BreastClass I Phosphatidylinositol 3-KinasesDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansMiddle AgedBevacizumabBiomarkers, TumorCarboplatinClass I Phosphatidylinositol 3-KinasesDoxorubicinErb-b2 Receptor Tyrosine Kinasesliposomal doxorubicinPIK3CA protein, humanPolyethylene GlycolsReceptors, EstrogenReceptors, ProgesteronePathological complete responsePIK3CA H1047R mutationTriple-negative breast cancer

Identifiers

PMID32019278
PMCPMC7373870
OpenAlexW3004753443

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.