Evidence map›Paper›PMID 23569315›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Multicenter phase II study of neoadjuvant lapatinib and trastuzumab with hormonal therapy and without chemotherapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer: TBCRC 006.

Mothaffar F Rimawi, Ingrid A Mayer, Andres Forero, Rita Nanda, Matthew P Goetz, Angel A Rodriguez, Anne C Pavlick, Tao Wang, Susan G Hilsenbeck, Carolina Gutierrez and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. 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 134 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 5 pooled it
16.2field-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.

NCT01973660 phase2completednot on this map

PAMELA: PAM50 HER2-enriched Phenotype as a Predictor of Early Response to Neoadjuvant Lapatinib Plus Trastuzumab in Stage I to IIIA HER2-positive Breast Cancer

TypeinterventionalSponsorSOLTI Breast Cancer Research GroupRan2013 to 2017Enrolled151ConditionsBreast CancerArmsLapatinib, Trastuzumab, Endocrine Therapy, Paclitaxel
NCT03272477 phase2completednot on this mapstarted 2017, after this paper: background citation

A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy Given for Twelve Weeks With a Quality of Life Assessment of Trastuzumab, Pertuzumab in Combination With Standard (Neo)Adjuvant Treatment in Patients With Operable HER2+/HR+ Breast Cancer.

TypeinterventionalSponsorPalleos Healthcare GmbHRan2017 to 2024Enrolled257ConditionsBreast NeoplasmsArmsPerjeta Injectable Product, Herceptin, Tamoxifen, Paclitaxel, Epirubicin
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 5 syntheses or guidelines pooled it, 272 citations in OpenAlex.

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  13. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).European journal of cancer (Oxford, England : 1990) · 2021
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  18. TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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74 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Mothaffar F RimawiBaylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA. rimawi@bcm.edu
Ingrid A Mayer
Andres Forero
Rita Nanda
Matthew P Goetz
Angel A Rodriguez
Anne C Pavlick
Tao Wang
Susan G Hilsenbeck
Carolina Gutierrez
Rachel Schiff
C Kent Osborne
Jenny C Chang

Funding

Tumor BiologyP30CA125123 · NCI · BAYLOR COLLEGE OF MEDICINE · PI Michael M Ittmann · 2007 to 2026
$73.9M
TUMOR SUPPRESSOR GENES IN BREAST CANCER DEVELOPMENTP50CA058183 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR SAN ANT · PI GUTIERREZ, CAROLLINA · 1992 to 2012
$30.9M
Targeted Therapies in Breast CancerK23CA127469 · NCI · VANDERBILT UNIVERSITY · PI MAYER, INGRID A · 2009 to 2013
$820k
NCI NIH HHS K23 CA127469NCI NIH HHS P30 CA125123NCI NIH HHS P50 CA058183NCI NIH HHS P50 CA58183
6 · The paper itself

Abstract

purposeWe previously reported the eradication of human epidermal growth factor receptor 2 (HER2)- amplified human xenografts in mice by inhibition of the HER2 pathway with lapatinib and trastuzumab to block all homo- and heterodimer signaling as well as by blockade of estrogen receptor (ER) when expressed. In this clinical trial, we sought to translate these findings to patients using targeted therapy without chemotherapy. PATIENTS AND

methodWomen with stages II to III HER2-positive breast cancers were eligible. They received trastuzumab once per week (4 mg/kg loading, then 2 mg/kg) and lapatinib 1000 mg once per day for 12 weeks. Women with ER-positive tumors also received letrozole (plus a luteinizing hormone-releasing hormone [LHRH] agonist if premenopausal). Pathologic response was assessed by ER status. Biopsies were obtained at baseline, weeks 2 and 8, and time of surgery.

resultsSixty-six patients were enrolled, and 64 were eligible and evaluable for response. Median tumor size was 6 cm (range, 1.5 to 30 cm). Adverse events were mainly grades 1 to 2 (GI, 63%; skin, 46%). Grade 3 metabolic, GI, and liver (18%; 12 patients) and grade 4 liver toxicities (one patient) were also observed. Overall, in-breast pathologic complete response (pCR; ypT0-is) was 27% (ER positive, 21%; ER negative, 36%). The rate of low-volume residual disease (ypT1a-b) was 22% (ER positive, 33%; ER negative, 4%).

conclusionIn patients with locally advanced HER2-positive breast cancer, our approach of targeted therapy only resulted in a high pCR rate without chemotherapy. Our data support the hypothesis that selected patients with HER2-positive tumors may not need chemotherapy, and more-complete blockade of HER receptors and ER is an effective strategy worthy of further study.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDrug Administration ScheduleErb-b2 Receptor Tyrosine KinasesFemaleHumansLapatinibLetrozoleLymphatic MetastasisMiddle AgedNeoadjuvant TherapyNeoplasm StagingAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibLetrozoleNitrilesQuinazolinesReceptors, EstrogenTrastuzumabTriazoles

Identifiers

PMID23569315
PMCPMC3641695
OpenAlexW2147299492

What OpenQuestion holds

Textmetadata
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.