Evidence map›Paper›PMID 32988996›Full record

Trial reportESMO open2020

Pertuzumab and trastuzumab emtansine in patients with HER2-amplified metastatic colorectal cancer: the phase II HERACLES-B trial.

Andrea Sartore-Bianchi, Sara Lonardi, Cosimo Martino, Elisabetta Fenocchio, Federica Tosi, Silvia Ghezzi, Francesco Leone, Francesca Bergamo, Vittorina Zagonel, Fortunato Ciardiello and 15 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2020. 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 98 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 3 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT03225937 phase2unknown statusnot on this map

Open-Label, Phase II Study of Trastuzumab in Combination With Lapatinib (Cohort A) or Pertuzumab in Combination With Trastuzumab-emtansine (Cohort B) in Patients With HER2-positive Metastatic Colorectal Cancer: the HERACLES (HER2 Amplification for Colo-rectaL Cancer Enhanced Stratification)Trial

TypeinterventionalSponsorFondazione del Piemonte per l'OncologiaRan2012 to 2019Enrolled54ConditionsMetastatic Colorectal CancerArmsTrastuzumab, Lapatinib, Pertuzumab, trastuzumab-emtansine
NCT05493683 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

A Single Arm, Open Label, Multiple Center, Prospective Study of Disitamab Vedotin Combined With Tislelizumab in HER2 Positive Advanced Colorectal Cancer Failed at Least Two Lines of Systemic Treatment.

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2022 to 2025Enrolled29ConditionsColorectal NeoplasmsArmsDisitamab vedotin, Tislelizumab
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 3 syntheses or guidelines pooled it, 176 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
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  6. Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  7. Review
  8. Article
  9. Article
  10. Review
  11. ESMO gastrointestinal oncology · 2026
    Article
  12. Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  13. Review
  14. Review
  15. Article
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  18. HER2-targeted therapy in colorectal cancer: a comprehensive review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  19. Article
  20. Review

38 more citing papers are in PubMed but not listed here.

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

25 authors at 8 institutions in 1 country.

Andrea Sartore-BianchiNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy; Dipartimento di Oncologia ed Emato-Oncologia, Università degli Studi di Milano (La Statale), Milano, Italy.
Sara LonardiOncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.
Cosimo MartinoCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.
Elisabetta FenocchioMultidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy.
Federica TosiNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Silvia GhezziNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Francesco LeoneDepartment of Oncology, ASL BI, Ospedale degli Infermi di Biella, Biella, Italy.
Francesca BergamoOncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.
Vittorina ZagonelOncologia Medica 1, Istituto Oncologico Veneto - IRCCS, Padova, Italy.
Fortunato CiardielloPrecision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Caserta, Campania, Italy.
Andrea ArdizzoniUOC Oncologia Medica, Policlinico S. Orsola, Dipartimento di Medicina Specialistica, di Laboratorio e Sperimentale, Università Alma Mater, Bologna, Italy.
Alessio AmatuNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Katia BencardinoNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Emanuele ValtortaNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Elena GrassiCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Scienze Mediche, Università degli Studi di Torino, Torino, Italy.
Valter TorriDipartimento di Oncologia, IRCCS- Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
Emanuela BonoldiNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Anna SapinoCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Scienze Mediche, Università degli Studi di Torino, Torino, Italy.
Angelo VanzulliNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy; Dipartimento di Oncologia ed Emato-Oncologia, Università degli Studi di Milano (La Statale), Milano, Italy.
Daniele ReggeCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Scienze Chirurgiche, Università degli Studi di Torino, Torino, Italy.
Giovanni CappelloCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Scienze Chirurgiche, Università degli Studi di Torino, Torino, Italy.
Alberto BardelliCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Oncologia, Università degli Studi di Torino, Torino, Italy.
Livio TrusolinoCandiolo Cancer Institute FPO-IRCCS, Candiolo (TO), Italy; Dipartimento di Oncologia, Università degli Studi di Torino, Torino, Italy.
Silvia MarsoniPrecision Oncology, IFOM-FIRC Institute of Molecular Oncology, Milano, Italy.
Salvatore SienaNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milano, Italy; Dipartimento di Oncologia ed Emato-Oncologia, Università degli Studi di Milano (La Statale), Milano, Italy. Electronic address: salvatore.siena@unimi.it.
Candiolo Cancer Institute · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITIstituto Oncologico Veneto · ITUniversity of Milan · ITIFOM · ITMario Negri Institute for Pharmacological Research · ITOspedale degli Infermi · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHER2 is a therapeutic target for metastatic colorectal cancer (mCRC), as demonstrated in the pivotal HERACLES-A (HER2 Amplification for Colo-rectaL cancer Enhanced Stratification) trial with trastuzumab and lapatinib. The aim of HERACLES-B trial is to assess the efficacy of the combination of pertuzumab and trastuzumab-emtansine (T-DM1) in this setting.

methodsHERACLES-B was a single-arm, phase II trial, in patients with histologically confirmed

resultsThirty-one patients, 48% with ≥4 lines of previous therapies, were treated and evaluable. ORR was 9.7% (95% CI: 0 to 28) and stable disease (SD) 67.7% (95% CI: 50 to 85). OR/SD ≥4 months was associated with higher HER2 immunohistochemistry score (3+ vs 2+) (p = 0.03). Median PFS was 4.1 months (95% CI: 3.6 to 5.9). Drug-related grade (G) 3 adverse events were observed in two patients (thrombocytopaenia); G≤2 AE in 84% of cycles (n = 296), mainly nausea and fatigue.

conclusionsHERACLES-B trial did not reach its primary end point of ORR; however, based on high disease control, PFS similar to other anti-HER2 regimens, and low toxicity, pertuzumab in combination with T-DM1 can be considered for HER2+mCRC as a potential therapeutic resource. TRIAL REGISTRATION NUMBER: 2012-002128-33 and NCT03225937.

Indexed as

Colorectal NeoplasmsRectal NeoplasmsAdo-Trastuzumab EmtansineAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesHumansAdo-Trastuzumab EmtansineAntibodies, Monoclonal, HumanizedBiomarkers, TumorErb-b2 Receptor Tyrosine KinasespertuzumabcolorectalERBB2HER2pertuzumabT-DM1

Identifiers

PMID32988996
PMCPMC7523198
OpenAlexW3088411120

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.