Evidence map›Paper›PMID 40796347›Full record

Trial reportJournal of the National Cancer Institute2025

Predicting ovarian function loss after chemotherapy and anti-HER2 therapy in young breast cancer patients.

Matteo Lambertini, Deirdre Allegranza, Ruediger P Laubender, Nadia Harbeck, Sandra M Swain, Charles E Geyer, Dennis J Slamon, Gabriella Bobba, Chiara Lambertini, Sanne de Haas and 6 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2025. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT00625898 phase3terminatednot on this map

A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

TypeinterventionalSponsorNSABP Foundation IncRan2008 to 2014Enrolled3,509ConditionsBreast CancerArmsDocetaxel, Trastuzumab, Carboplatin, Bevacizumab, 5-Fluorouracil
NCT01966471 phase3completednot on this map

A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2021Enrolled1,846ConditionsBreast CancerArmsTrastuzumab Emtansine, Trastuzumab, Pertuzumab, Paclitaxel, Epirubicin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Matteo LambertiniDepartment of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genova, Genoa, Italy.ORCID 0000-0003-1797-5296
Deirdre AllegranzaClinical Development and Medical Affairs, Roche Diagnostics International Ltd, Rotkreuz, Switzerland.ORCID 0009-0001-5838-2887
Ruediger P LaubenderBiostatistics & Data Science Core Lab & Near Patient Care, Roche Diagnostics GmbH, Penzberg, Germany.
Nadia HarbeckBreast Center, Department of OB&GYN and CCC Munich, LMU University Hospital, Munich, Germany.ORCID 0000-0002-9744-7372
Sandra M SwainGeorgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, DC, United States.ORCID 0000-0002-1320-3830
Charles E GeyerDepartment of Medicine, UPMC Hillman Cancer Center, Pittsburgh, PA, United States.ORCID 0000-0002-2379-5702
Dennis J SlamonDavid Geffen School of Medicine at UCLA, Los Angeles, CA, United States.ORCID 0000-0002-6330-498X
Gabriella BobbaClinical Development and Medical Affairs, Roche Diagnostics International Ltd, Rotkreuz, Switzerland.
Chiara LambertiniTranslational Medicine Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Sanne de HaasTranslational Medicine Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Eleonora RestucciaProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.ORCID 0000-0001-5751-094X
Ines Vaz-LuisCancer Survivorship Group, Inserm Unit 981, Gustave Roussy, Villejuif, France.ORCID 0000-0002-7194-2260
David A CameronInstitute of Genetics and Cancer, Western General Hospital-NHS Lothian, Edinburgh, United Kingdom.ORCID 0000-0002-2717-7979
Ian E KropYale Cancer Center, Yale School of Medicine, New Haven, CT, United States.ORCID 0000-0002-6380-5944
Eric P WinerYale Cancer Center, Yale School of Medicine, New Haven, CT, United States.ORCID 0000-0002-8819-1723
Richard A AndersonCentre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, United Kingdom.ORCID 0000-0002-7495-518X

Funding

AstraZenecaF. Hoffmann-La Roche LtdNSABP FoundationRoche Diagnostics International Ltd
6 · The paper itself

Abstract

backgroundThe ability to predict ovarian function loss after anticancer treatment is important for appropriate oncofertility counseling and to aid in therapy decision-making for young women with early breast cancer (eBC).

methodsThis biomarker analysis of the BETH (NCT00625898) and KAITLIN (NCT01966471) randomized trials investigated anti-Müllerian hormone (AMH) use, alone and combined with follicle stimulating hormone (FSH) and estradiol (E2), for predicting ovarian function loss following currently adopted chemotherapy and anti-HER2 therapy in premenopausal women with HER2-positive eBC. Serum samples were centrally tested measuring AMH, FSH, and E2 using Roche Elecsys assays.

resultsAmong 194 included patients (BETH: n = 62; KAITLIN: n = 132), AMH values declined from baseline median 8.44 pmol L-1 to undetectable levels (<0.07 pmol L-1) at the end of therapy, with partial recovery at 36 months (median 0.14 pmol L-1). AMH measured at baseline was predictive of ovarian loss (area under the ROC curve [AUC] = 0.784). Addition of age to AMH slightly improved AUC to 0.800. AMH measured at the end of therapy had AUC 0.741, which increased to 0.785 with addition of age. The combination of AMH at baseline and end of therapy increased prediction to 0.808 and with addition of age to 0.820. Addition of baseline FSH and E2 did not improve prediction in any analysis.

conclusionsThese results support the use of pretreatment measurement of AMH in predicting ovarian function loss in premenopausal women with HER2-positive eBC receiving chemotherapy and anti-HER2 therapy. Measurement of AMH at the end of treatment had reduced accuracy than pretreatment but in combination added slightly to the value of pretreatment sampling.

Indexed as

Anti-Mullerian HormoneAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesOvaryPrimary Ovarian InsufficiencyAdultEstradiolFemaleFollicle Stimulating HormoneHumansPremenopauseYoung AdultAnti-Mullerian HormoneERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesEstradiolFollicle Stimulating Hormone

Identifiers

PMID40796347
PMCPMC12597502

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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.