Evidence map›Paper›PMID 34312774›Full record

Trial reportJournal of assisted reproduction and genetics2021

Concomitant tamoxifen or letrozole for optimal oocyte yield during fertility preservation for breast cancer: the TAmoxifen or Letrozole in Estrogen Sensitive tumors (TALES) randomized clinical trial.

Joseph Letourneau, Flor Juarez-Hernandez, Kaitlyn Wald, Salustiano Ribeiro, Ange Wang, Charles E McCulloch, Evelyn Mok-Lin, Milana Dolezal, A Jo Chien, Marcelle I Cedars and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of assisted reproduction and genetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03011684 (Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT03011684 phase3recruitingnot on this map

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2016 to 2028Enrolled309ConditionsInfertilityArmsTamoxifen, Letrozole
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  4. Review
  5. Article
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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

11 authors at 2 institutions in 1 country.

Joseph LetourneauDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA. Joseph.letourneau@hsc.utah.edu.ORCID http://orcid.org/0000-0001-9966-5851
Flor Juarez-HernandezDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Kaitlyn WaldDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Salustiano RibeiroDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Ange WangDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Charles E McCullochDepartment of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.
Evelyn Mok-LinDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Milana DolezalHematology and Oncology, California Pacific Medical Center Research Institute, San Francisco, CA, USA.
A Jo ChienDepartment of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Marcelle I CedarsDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Mitchell RosenDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
University of California, San Francisco · USCalifornia Pacific Medical Center · US

Funding

University of California, San Francisco n/a
6 · The paper itself

Abstract

purposeTo determine whether concomitant tamoxifen 20 mg with gonadotropins (tamoxifen-gonadotropin) versus letrozole 5 mg with gonadotropins (letrozole-gonadotropin) affects mature oocyte yield.

methodsOpen-label, single-institution, randomized trial. Inclusion criteria included the following: females, ages 18-44 years old, with new diagnosis of non-metastatic breast cancer, who were undergoing fertility preservation with either oocyte or embryo cryopreservation. Those with estrogen-receptor-positive (ER+) breast cancer were randomized to tamoxifen-gonadotropin or letrozole-gonadotropin. Another group with estrogen-receptor-negative (ER-) breast cancer was recruited, as a prospectively collected comparison arm who took neither letrozole nor tamoxifen (gonadotropin only). The primary outcome was the number of mature oocytes obtained from the cycle. The randomized groups were powered to detect a difference of three or more mature oocytes.

resultsForty-five patients were randomized to tamoxifen-gonadotropin and fifty-one to letrozole-gonadotropin. Thirty-eight patients completed gonadotropin only. Age, antral follicle count, and body mass index were similar between the randomized groups. Our primary outcome of mature oocyte yield was similar between the tamoxifen-gonadotropin and letrozole-gonadotropin groups (12±8.6 vs. 11.6±7.5, p=0.81, 95%CI of difference =-2.9 to 3.7). In a pre-specified secondary comparison, mature oocyte yield was also similar with tamoxifen-gonadotropin or letrozole-gonadotropin versus gonadotropin only (12±8.6 vs. 11.6±7.5 vs. 12.4±7.2). There were no serious adverse events in any of the groups.

conclusionsTamoxifen-gonadotropin and letrozole-gonadotropin produced a similar number of mature oocytes. Women who received either tamoxifen-gonadotropin or letrozole-gonadotropin had a similar number of oocytes to the gonadotropin-only group.

trial registrationNCT03011684 (retrospectively registered 1/5/2017, after 9% enrolled).

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCryopreservationDose-Response Relationship, DrugDrug Therapy, CombinationEmbryo, MammalianFemaleFertility PreservationGonadotropinsHumansInfertility, FemaleLetrozoleOocytesOvulation InductionGonadotropinsLetrozoleTamoxifenBreast cancerFertility preservationLetrozoleOvarian stimulationTamoxifen

Identifiers

PMID34312774
PMCPMC8490576
OpenAlexW3186909721

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.