Evidence map›Paper›PMID 41642486›Full record

Trial reportBreast cancer (Tokyo, Japan)2026

Venlafaxine reduces hot flashes in hormone receptor-positive breast cancer patients receiving tamoxifen: a prospective single-arm, open-label trial.

Riko Sato, Rena Kamohara, Tomohei Matsuo, Aya Sawa, Mai Okazaki, Sachie Hashimoto, Akiko Iguchi-Manaka, Hisato Hara, Kosuke Doki, Yuji Mukai and 4 more

Abstract readClinical Trial
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 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

14 authors.

Riko SatoDepartment of Breast-Thyroid-Endocrine Surgery, University of Tsukuba Hospital, Tsukuba, Japan.ORCID http://orcid.org/0009-0001-1656-6629
Rena KamoharaDepartment of Breast-Thyroid-Endocrine Surgery, University of Tsukuba Hospital, Tsukuba, Japan.
Tomohei MatsuoDepartment of Breast-Thyroid-Endocrine Surgery, University of Tsukuba Hospital, Tsukuba, Japan.
Aya SawaDepartment of Breast-Thyroid-Endocrine Surgery, University of Tsukuba Hospital, Tsukuba, Japan.
Mai OkazakiDepartment of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Sachie HashimotoDepartment of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Akiko Iguchi-ManakaDepartment of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Hisato HaraDepartment of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Kosuke DokiDepartment of Pharmacy, University of Tsukuba Hospital, Tsukuba, Japan.
Yuji MukaiDepartment of Pharmacy, University of Tsukuba Hospital, Tsukuba, Japan.
Masato HommaDepartment of Pharmacy, University of Tsukuba Hospital, Tsukuba, Japan.
Ryota IshiiDepartment of Biostatistics, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Kensuke ShimadaDepartment of Clinical Research and Regional Innovation, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroko BandoDepartment of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan. bando@md.tsukuba.ac.jp.ORCID http://orcid.org/0000-0002-7361-3647

Funding

Grant for Implementation of Advanced Medicine 107
6 · The paper itself

Abstract

backgroundAlthough venlafaxine has shown efficacy for hot flashes in hormone receptor–positive breast cancer, evidence in Asian women (especially premenopausal) remains limited. Hot flashes reduce endocrine therapy adherence and severity may increase with ovarian suppression. We conducted a prospective, single-arm, open-label study to evaluate the efficacy and safety of venlafaxine in tamoxifen-treated patients with moderate-to-severe hot flashes.

methodsTwenty patients received venlafaxine at 37.5 mg/day for 4 weeks, with optional escalation to 75 mg/day. Weekly hot flash scores, adverse events, and serum concentrations of tamoxifen, its metabolites, and venlafaxine (as well as CYP2D6 genotype associations) were assessed. Of the 20 patients, 17 were included in the primary efficacy analysis, 20 in the safety population for adverse events, and 18 in the pharmacokinetic analysis.

resultsAt Week 4, hot flash scores declined by 49.8% from baseline (P < 0.001). Venlafaxine did not affect serum concentrations of tamoxifen or its metabolites. CYP2D6 intermediate metabolizers had higher venlafaxine concentrations than extensive metabolizers (P = 0.007), although symptom improvement occurred regardless of genotype. All adverse events were Grade 1–2.

conclusionsThese findings demonstrate that venlafaxine safely and effectively alleviates hot flashes in hormone receptor-positive breast cancer patients undergoing tamoxifen-based endocrine therapy.

Indexed as

Antineoplastic Agents, HormonalBreast NeoplasmsHot FlashesTamoxifenVenlafaxine HydrochlorideAdultAgedCytochrome P-450 CYP2D6FemaleGenotypeHumansMiddle AgedProspective StudiesReceptors, EstrogenReceptors, ProgesteroneTreatment OutcomeAntineoplastic Agents, HormonalCytochrome P-450 CYP2D6Receptors, EstrogenReceptors, ProgesteroneTamoxifenVenlafaxine HydrochlorideBreast cancerCYP2D6Hot flashesTamoxifenVenlafaxine

Identifiers

PMID41642486
PMCPMC12960305

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.