Evidence map›Paper›PMID 42258966›Full record

Trial reportESMO open2026

Scalp cooling outcomes in patients receiving trastuzumab deruxtecan for metastatic breast cancer.

E Salehi, X Chu, E L Mayer, S Singer, G Augdahl, M Stalteri, T Li, K E Dibble, N Sinclair, M Faggen and 8 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

E SalehiDana-Farber Cancer Institute, Boston, USA.
X ChuDana-Farber Cancer Institute, Boston, USA.
E L MayerDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
S SingerDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
G AugdahlDana-Farber Cancer Institute, Boston, USA.
M StalteriDana-Farber Cancer Institute, Boston, USA.
T LiDana-Farber Cancer Institute, Boston, USA.
K E DibbleDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
N SinclairDana-Farber Brigham Cancer Center, Milford, USA.
M FaggenDana-Farber Brigham Cancer Center, South Weymouth, USA.
J WalshDana-Farber/New Hampshire Oncology, Londonderry, USA.
S SammonsDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
K SendrickDana-Farber Cancer Institute, Boston, USA.
S HannaDana-Farber Cancer Institute, Boston, USA.
A MostaghimiHarvard Medical School, Boston, USA; Brigham and Women's Hospital, Boston, USA.
N TayobDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
N R LeBoeufDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Brigham and Women's Hospital, Boston, USA.
S M TolaneyDana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA. Electronic address: Sara_Tolaney@dfci.harvard.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrastuzumab deruxtecan (T-DXd) has improved outcomes for many patients with metastatic breast cancer (MBC). T-DXd is associated with alopecia, yet limited data exist describing the efficacy of scalp cooling (SC) in preventing alopecia among patients receiving T-DXd. PATIENTS AND

methodsThis prospective, phase II trial evaluated the efficacy of SC among patients with MBC receiving T-DXd. Conducted at Dana-Farber Cancer Institute, the trial enrolled patients with MBC without alopecia at baseline, initiating treatment with T-DXd. Participants elected either the SC arm, using the Paxman Scalp Cooling System, or the non-SC arm. The primary endpoint was hair loss rate, defined as locally assessed Common Terminology Criteria for Adverse Events (version 5.0) grade ≥1 alopecia occurring at cycle 3, day 1; cycle 5, day 1; or end of treatment, whichever occurred first.

resultsAmong 40 enrolled evaluable patients, 33 (82.5%) patients [18 (90%) in the SC arm and 15 (75%) in the non-SC arm] experienced grade ≥1 alopecia. The difference in rates between arms was not statistically significant (P = 0.41). Grade 2 alopecia rates were the same in both arms (55%). Centralized image review revealed no significant differences in grade ≥1 (P = 1.00) or grade 2 alopecia (P = 0.33) between treatment arms. Grade 2 alopecia was the primary reason for SC discontinuation (45%). The median time to grade 2 alopecia was 2.76 months [95% confidence interval (CI), 1.64-NA] in the SC arm; 4.60 months (95% CI, 2.53-NA) in the non-SC arm (P = 0.7).

conclusionsSC with T-DXd did not reduce alopecia rates. Small sample size and lack of randomization may have limited the interpretation. Further studies are crucial to improve SC's efficacy with antibody-drug conjugate therapy.

Indexed as

AlopeciaBreast NeoplasmsHypothermia, InducedImmunoconjugatesScalpTrastuzumabAdultAgedAntineoplastic Agents, ImmunologicalCamptothecinFemaleHumansMiddle AgedProspective StudiesTreatment OutcomeAntineoplastic Agents, ImmunologicalCamptothecinImmunoconjugatesTrastuzumabtrastuzumab deruxtecanalopeciaantibody-drug conjugatesmetastatic breast cancerscalp coolingtrastuzumab deruxtecan

Identifiers

PMID42258966
PMCPMC13264033

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.