Evidence map›Paper›PMID 41628308›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026

Pharmacodynamics of Camizestrant Treatment in Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer: Results From the Randomized, Presurgical SERENA-3 Study.

John F R Robertson, Teimuraz Gogitidze, Zaza Katashvili, Juan Enrique Bargalló Rocha, Ekaterine Arkania, Iain Moppett, Kwok-Leung Cheung, Gia Nemsadze, Maxine Ajimi, Teresa Klinowska and 7 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

17 authors.

John F R RobertsonUniversity Hospitals of Derby and Burton, Royal Derby Hospital, Derby, United Kingdom.ORCID 0000-0001-6212-3979
Teimuraz GogitidzeLTD Brothers, Batumi, Ajaria, Georgia.
Zaza KatashviliAcad. Fridon Todua Medical Center, Research Institute of Clinical Medicine, Tbilisi, Georgia.
Juan Enrique Bargalló RochaInstituto Nacional de Cancerologia (INCAN), Mexico City, Mexico.
Ekaterine ArkaniaHelsicore Israeli Georgian Medical Research Clinic, Tbilisi, Georgia.ORCID 0009-0001-5682-9753
Iain MoppettInjury, Recovery and Inflammation Sciences, University of Nottingham, Nottingham, United Kingdom.ORCID 0000-0003-3750-6067
Kwok-Leung CheungUniversity Hospitals of Derby and Burton, Royal Derby Hospital, Derby, United Kingdom.ORCID 0000-0003-2973-0755
Gia NemsadzeThe Institute of Clinical Oncology, Tbilisi, Georgia.
Maxine AjimiResearch and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Teresa KlinowskaLate Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Justin P O LindemannResearch and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.ORCID 0000-0003-1531-9754
Alastair MathewsonResearch and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.ORCID 0009-0000-2435-9235
Christopher J MorrowResearch and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.ORCID 0000-0003-1524-9426
Myria NikolaouResearch and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Maurizio ScaltritiResearch and Early Development, Oncology R&D, AstraZeneca, Gaithersburg, MD.
Andy SykesClinical Pharmacology and Safety Sciences, Biopharmaceutical Sciences, AstraZeneca, Cambridge, United Kingdom.
Giorgi DzagnidzeLTD S. Khechinashvili University Hospital, Tbilisi, Georgia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSERENA-3 is a presurgical window-of-opportunity (WOO) trial exploring the pharmacodynamic effects of camizestrant in postmenopausal women with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative breast cancer.

methodsThis open-label, parallel-group trial randomly assigned 132 participants to receive camizestrant 75, 150, or 300 mg once daily for 5-7 days or 75 or 150 mg once daily for 12-15 days. The effects of camizestrant on ER expression, activity, and tumor proliferation were assessed in pre- and on-treatment tumor samples by immunohistochemical (IHC) analysis of ER, progesterone receptor (PgR), and Ki67. Exploratory analyses using transcriptomics and mass spectrometry were also performed.

resultsER expression was reduced by approximately 65% for all camizestrant doses, regardless of treatment duration. Reduction in Ki67 expression was greater after 12-15 days of camizestrant treatment, compared with 5-7 days. Exploratory analyses including mass spectrometry and IHC image analysis aligned with IHC H-score, indicating equivalent, maximal effects of all tested doses of camizestrant on ER expression and activity and Ki67 expression. Of those participants receiving camizestrant 75 mg once daily, 90%-100% reported no treatment-emergent adverse events across all preferred terms; of those reported, all were Grade 1 except one participant with Grade 2 upper respiratory tract infection, not considered related to camizestrant.

conclusionSERENA-3 demonstrates that camizestrant 75 mg once daily (Phase III dose) is well-tolerated and achieves maximal reduction in ER through known mechanisms, that is, antagonism and degradation, by 5-7 days, and proliferation suppression determined by Ki67 expression, by 12-15 days. These data support camizestrant 75 mg once daily as the preferred dose for ongoing clinical development and highlight the importance of presurgical WOO studies in guiding dose selection.

Indexed as

AzetidinesBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesIsoquinolinesReceptors, EstrogenAgedCell ProliferationFemaleHumansKi-67 AntigenMiddle AgedNeoadjuvant TherapyPostmenopauseReceptors, ProgesteroneAZD9833AzetidinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesIsoquinolinesKi-67 AntigenMKI67 protein, humanReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID41628308
PMCPMC13001899

What OpenQuestion holds

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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 OpenQuestion graph.