Evidence map›Paper›PMID 33109627›Full record

Trial reportESMO open2020

Phase II trial of ribociclib and letrozole in patients with relapsed oestrogen receptor-positive ovarian or endometrial cancers.

Gerardo Colon-Otero, Valentina Zanfagnin, Xiaonan Hou, Nathan R Foster, Erik J Asmus, Andrea Wahner Hendrickson, Aminah Jatoi, Matthew S Block, Carrie L Langstraat, Gretchen E Glaser and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02657928 (A Phase 2 Trial of Ribociclib), which is not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
4.8field-weighted citation impact, top 4% 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.

NCT02657928 phase2completednot on this map

A Phase 2 Trial of Ribociclib (LEE011) and Letrozole in ER Positive Relapsed Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinomas, and Endometrial Cancers.

TypeinterventionalSponsorMayo ClinicRan2016 to 2020Enrolled40ConditionsEstrogen Receptor Positive, Postmenopausal, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian CarcinomaArmsLaboratory Biomarker Analysis, Letrozole, Ribociclib
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 90 citations in OpenAlex.

  1. Trial
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  3. A Phase II Study of Fulvestrant plus Abemaciclib in Hormone Receptor-Positive Advanced or Recurrent Endometrial Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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  5. A phase II, multicenter, open-label study of abemaciclib and letrozole in patients with estrogen receptor-positive rare ovarian cancer: ALEPRO trial.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Trial
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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

16 authors at 4 institutions in 1 country.

Gerardo Colon-OteroHematology/Oncology, Mayo Clinic Florida, Jacksonville, Florida, USA. Electronic address: gcolonotero@mayo.edu.
Valentina ZanfagninDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Xiaonan HouDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Nathan R FosterDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
Erik J AsmusDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
Andrea Wahner HendricksonDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Aminah JatoiDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Matthew S BlockDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Carrie L LangstraatDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Gretchen E GlaserDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Tri A DinhDepartment of Medical & Surgical Gynecology, Mayo Clinic Florida, Jacksonville, Florida, USA.
Matthew W RobertsonDepartment of Medical & Surgical Gynecology, Mayo Clinic Florida, Jacksonville, Florida, USA.
John K CamorianoDivision of Hematology and Medical Oncology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.
Kristina A ButlerDivision of Hematology and Medical Oncology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.
John A CoplandDepartment of Cancer Biology, Mayo Clinic Florida, Jacksonville, Florida, USA.
S John WerohaDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Mayo Clinic · USJacksonville College · USMayo Clinic in Arizona · USMayo Clinic in Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe describe a phase II clinical trial of the combination of ribociclib and letrozole for treatment of relapsed oestrogen receptor (ER)-positive ovarian cancer (OC) and endometrial cancer (EC). The primary endpoint was the proportion of patients alive, progression-free survival (PFS), and still on treatment at 12 weeks (PFS12), with 45% or greater considered positive.

methodsPatients with measurable, relapsed ER-positive OC or EC (platinum-sensitive or resistant) were eligible and treated with 400 mg of oral ribociclib and 2.5 mg of oral letrozole daily. Patient-derived xenografts (PDXs) were created from imaging-guided tumour biopsies.

resultsForty patients (20 OC and 20 EC) were enrolled. A PFS12 of 55% was observed in the EC cohort and 50% in the OC cohort. A PFS greater or equal to 24 weeks (PFS24) was seen in 20% (4/20) of the OC cohort and 35% (7/20) of the EC cohort. The greatest benefit was seen in low-grade serous OC (LGSOC) (3/3, 100% PFS24) and grades 1 and 2 EC (5/11, 45% PFS24). All three LGSOC patients obtained at least a partial response lasting for over 2 years, with two of the three patients still on treatment. PDX tumour engraftment was feasible in 45% of patients. Positive survival effects of the combination of ribociclib and letrozole were observed in two of three EC PDX models.

conclusionRibociclib and letrozole have promising clinical activity in relapsed ER-positive OC and EC, particularly in LGSOC and relapsed ER-positive grade 1 and 2 EC. Generation of PDX models is feasible with positive survival effects observed in EC models. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT02657928).

Indexed as

Endometrial NeoplasmsReceptors, EstrogenAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleHumansLetrozoleNeoplasm Recurrence, LocalPurinesAminopyridinesLetrozolePurinesReceptors, Estrogenribociclibendometrial cancerletrozoleovarian cancerribociclib

Identifiers

PMID33109627
PMCPMC7592247
OpenAlexW3096728494

What OpenQuestion holds

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LicenceCC BY-NC
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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.