Evidence map›Paper›PMID 35538105›Full record

ArticleNPJ breast cancer2022

A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer.

Adrienne G Waks, Neelam V Desai, Tianyu Li, Philip D Poorvu, Ann H Partridge, Natalie Sinclair, Laura M Spring, Meredith Faggen, Michael Constantine, Otto Metzger and 11 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.8field-weighted citation impact, top 5% 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.

NCT03716180 phase1active not recruitingnot on this map

DAPHNe: De-escalation to Adjuvant Antibodies Post-pCR to Neoadjuvant THP (Paclitaxel/Trastuzumab/Pertuzumab)-a Pilot Study in HER2-positive Breast Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2018 to 2030Enrolled100ConditionsBreast CancerArmsPaclitaxel, Trastuzumab, Pertuzumab
NCT07220135 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2025 to 2031Enrolled100ConditionsBreast CancerArmsCarboplatin, Docetaxel, Trastuzumab (or biosimilar), Pertuzumab (or biosimilar)
NCT07421141 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

Prospective Non-Randomized Phase II Study of De-escalated Neoadjuvant Chemotherapy With Paclitaxel, Trastuzumab, and Pertuzumab (THP) Compared to Standard Regimen (TCHP) in Patients With Early HER2-Positive Breast Cancer

TypeinterventionalSponsorNational Medical Research Radiological Centre of the Ministry of Health of RussiaRan2023 to 2028Enrolled186ConditionsBreast Cancer, HER2-positive Breast Cancer, Early Breast CancerArmsPaclitaxel, trastuzumab, Pertuzumab, Docetaxel, carboplatin
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 40 citations in OpenAlex.

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  5. Headwinds in Breast Cancer Research: The Case for Pragmatic Radiotherapy De-escalation Studies.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  6. 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
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  19. Association of HER2DX with pathological complete response and survival outcomes in HER2-positive breast cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2023
    Article
  20. Review
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

21 authors at 5 institutions in 1 country.

Adrienne G Waks *Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Neelam V Desai *Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0001-8641-0542
Tianyu LiDepartment of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
Philip D PoorvuMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Ann H PartridgeMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-4722-4824
Natalie SinclairHarvard Medical School, Boston, MA, USA.
Laura M SpringHarvard Medical School, Boston, MA, USA.
Meredith FaggenHarvard Medical School, Boston, MA, USA.
Michael ConstantineHarvard Medical School, Boston, MA, USA.
Otto MetzgerMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Jillian AlbertiMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Julia DeaneMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Shoshana M RosenbergMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Elizabeth FrankMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Sara M TolaneyMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-5940-8671
Ian E KropMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-6380-5944
Nadine M TungHarvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0003-1422-3734
Nabihah TayobHarvard Medical School, Boston, MA, USA.
Tari A KingBreast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA.
Elizabeth A MittendorfBreast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA.
Eric P WinerMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Eric.winer@yale.edu.ORCID http://orcid.org/0000-0002-8819-1723
Harvard University · USDana-Farber Cancer Institute · USBeth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USAndover Eye Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

De-escalating adjuvant therapy following pathologic complete response (pCR) to an abbreviated neoadjuvant regimen in human epidermal growth factor receptor 2-positive (HER2+) breast cancer is the focus of international research efforts. However, the feasibility of this approach and its appeal to patients and providers had not been formally investigated. We aimed to assess adherence to de-escalated adjuvant antibody doublet therapy (trastuzumab and pertuzumab [HP], without chemotherapy) among patients with pCR following neoadjuvant paclitaxel/HP (THP). In this single-arm prospective trial, patients with treatment-naïve stage II-III HER2+ breast cancer received neoadjuvant weekly paclitaxel ×12 and HP every 3 weeks ×4. The primary endpoint was receipt of adjuvant non-HER2-directed cytotoxic chemotherapy. Ninety-eight patients received ≥1 dose of THP on study. Patients had median age of 50 years, 86% had stage II tumors, and 34% were hormone receptor-negative. Five patients had incomplete clinical response following THP and received doxorubicin and cyclophosphamide before surgery; they were classified as non-pCR and censored from further analyses. The overall pCR rate was 56.7%. Among patients with pCR, the adherence rate to de-escalated antibody-only therapy (HP) was 98.2% (95% CI 90.3-100.0%), and the primary feasibility endpoint was reached. The majority of patients felt positive or neutral about their adjuvant treatment plans. With brief follow-up (median 19.1 months), there were no breast cancer recurrences. De-escalation of adjuvant chemotherapy among patients who experience pCR in early-stage HER2+ breast cancer is a practicable approach for both patients and physicians. Planned and ongoing prospective trials will determine the long-term efficacy of this approach.Trial registration clinicaltrials.gov, NCT03716180, https://clinicaltrials.gov/ct2/show/NCT03716180 .

Identifiers

PMID35538105
PMCPMC9091255
OpenAlexW4229446258

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.