Evidence map›Paper›PMID 29664714›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2018

Randomized Phase II Trial of Fulvestrant Plus Everolimus or Placebo in Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy: Results of PrE0102.

Noah Kornblum, Fengmin Zhao, Judith Manola, Paula Klein, Bhuvaneswari Ramaswamy, Adam Brufsky, Phillip J Stella, Brian Burnette, Melinda Telli, Della F Makower and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01797120 (Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant), which is not on this map. Cited by 113 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 7 pooled it
16.3field-weighted citation impact, top 1% 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.

NCT01797120 phase2completednot on this map

Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy

TypeinterventionalSponsorPrECOG, LLC.Ran2013 to 2017Enrolled131ConditionsMetastatic Breast CancerArmsFulvestrant, Everolimus, Placebo
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 7 syntheses or guidelines pooled it, 188 citations in OpenAlex.

  1. SEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review of concepts in therapeutic decision-making in HER2-negative luminal metastatic breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Pooled it
  8. Trial
  9. Trial
  10. Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HRClinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  11. Trial
  12. Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer: results of phase IIIb BALLET trial in Spain.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Trial
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Article

53 more citing papers are in PubMed but not listed here.

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

19 authors at 1 institution in 1 country.

Noah KornblumNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Fengmin ZhaoNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Judith ManolaNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Paula KleinNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Bhuvaneswari RamaswamyNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Adam BrufskyNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Phillip J StellaNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Brian BurnetteNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Melinda TelliNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Della F MakowerNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Puneet CheemaNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Cristina I TruicaNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Antonio C WolffNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Gamini S SooriNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Barbara HaleyNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Timothy R WassenaarNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Lori J GoldsteinNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Kathy D MillerNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Joseph A SparanoNoah Kornblum, Della F. Makower, and Joseph A. Sparano, Albert Einstein College of Medicine, Bronx; Paula Klein, Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY; Fengmin Zhao and Judith Manola, Dana-Farber Cancer Institute, Boston, MA; Bhuvaneswari Ramaswamy, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Adam Brufsky, University of Pittsburgh, Pittsburgh; Cristina I. Truica, Penn State Cancer Institute, Hershey; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Phillip J. Stella, Saint Joseph Mercy (Michigan Cancer Consortium), Ann Arbor, MI; Brian Burnette, Saint Vincent Hospital, Green Bay; Timothy R. Wassenaar, Pro Health Care, Waukesha, WI; Melinda Telli, Stanford University School of Medicine, Stanford, CA; Puneet Cheema, Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, MN; Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Gamini S. Soori, Missouri Valley Cancer Consortium, Omaha, NE; Barbara Haley, UT Southwestern Medical Center, Dallas, TX; and Kathy D. Miller, Indiana University School of Medicine, Indianapolis, IN.
Regional Cancer Center · US

Funding

WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Dietmar J Kappes · 1985 to 2026
$138.8M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCI NIH HHS P30 CA006927NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

Purpose The mammalian target of rapamycin inhibitor everolimus targets aberrant signaling through the PI3K/AKT/mammalian target of rapamycin pathway, a mechanism of resistance to anti-estrogen therapy in estrogen receptor (ER)-positive breast cancer. We hypothesized that everolimus plus the selective ER downregulator fulvestrant would be more efficacious than fulvestrant alone in ER-positive metastatic breast cancer resistant to aromatase inhibitor (AI) therapy. Patients and Methods This randomized, double-blind, placebo-controlled, phase II study included 131 postmenopausal women with ER-positive, human epidermal growth factor receptor 2-negative, AI-resistant metastatic breast cancer randomly assigned to fulvestrant (500 mg days 1 and 15 of cycle 1, then day 1 of cycles 2 and beyond) plus everolimus or placebo. The study was designed to have 90% power to detect a 70% improvement in median progression-free survival from 5.4 months to 9.2 months. Secondary end points included objective response and clinical benefit rate (response or stable disease for at least 24 weeks). Prophylactic corticosteroid mouth rinses were not used. Results The addition of everolimus to fulvestrant improved the median progression-free survival from 5.1 to 10.3 months (hazard ratio, 0.61 [95% CI, 0.40 to 0.92]; stratified log-rank P = .02), indicating that the primary trial end point was met. Objective response rates were similar (18.2% v 12.3%; P = .47), but the clinical benefit rate was significantly higher in the everolimus arm (63.6% v 41.5%; P = .01). Adverse events of all grades occurred more often in the everolimus arm, including oral mucositis (53% v 12%), fatigue (42% v 22%), rash (38% v 5%), anemia (31% v. 6%), diarrhea (23% v 8%), hyperglycemia (19% v 5%), hypertriglyceridemia (17% v 3%), and pneumonitis (17% v 0%), although grade 3 to 4 events were uncommon. Conclusion Everolimus enhances the efficacy of fulvestrant in AI-resistant, ER-positive metastatic breast cancer.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodDrug SynergismErb-b2 Receptor Tyrosine KinasesEverolimusFemaleFulvestrantHumansMiddle AgedPostmenopauseReceptors, EstrogenAromatase InhibitorsBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesEverolimusFulvestrantReceptors, Estrogen

Identifiers

PMID29664714
PMCPMC7186582
OpenAlexW2799435517

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