Giredestrant Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Giredestrant comprises 20 peer-reviewed publications across 15 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Endometrial Neoplasms, and Breast Neoplasms. Most recent publication: Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study., J Clin Oncol, 2024.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study.
    Martín M, Lim E, Chavez-MacGregor M, et al. · J Clin Oncol · 2024
    PubMed: PMID 38537155 · NCT04576455 · Breast Neoplasms
  2. UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure.
    Malhi V, Nowicka M, Chen YC, et al. · Cancer Chemother Pharmacol · 2024
    PubMed: PMID 38305868 · NCT04576455 · Breast Neoplasms
  3. heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer.
    Kuemmel S, Harper-Wynne C, Park YH, et al. · BMC Cancer · 2024
    PubMed: PMID 38789924 · NCT05296798 · Breast Neoplasms
  4. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study.
    Hurvitz SA, Bardia A, Quiroga V, et al. · Lancet Oncol · 2023
    PubMed: PMID 37657462 · NCT04436744 · Breast Neoplasms
  5. Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.
    Westin SN, Sill MW, Coleman RL, et al. · Gynecol Oncol · 2019
    PubMed: PMID 31623857 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  6. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial.
    Rosenberg JE, Hoffman-Censits J, Powles T, et al. · Lancet · 2016
    PubMed: PMID 26952546 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  7. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial.
    Rini BI, Powles T, Atkins MB, et al. · Lancet · 2019
    PubMed: PMID 31079938 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  8. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency.
    Le DT, Uram JN, Wang H, et al. · N Engl J Med · 2015
    PubMed: PMID 26028255 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

Publications by year

19762024: 20 publications.

1976
1
2011
1
2013
1
2014
1
2015
2
2016
1
2017
4
2018
2
2019
3
2023
1
2024
3

Publications by indication

Endometrial Neoplasms (16)

  • Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.
    Gynecol Oncol · 2019 · PMID 31623857 · NCT04486352
  • Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial.
    Lancet · 2019 · PMID 31079938 · NCT04486352
  • Correction: A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors.
    Cancer Discov · 2019 · PMID 30385525 · NCT04486352
  • PARP Inhibitor Upregulates PD-L1 Expression and Enhances Cancer-Associated Immunosuppression.
    Clin Cancer Res · 2018 · PMID 28167507 · NCT04486352
  • Durable response in a woman with recurrent low-grade endometrioid endometrial cancer and a germline BRCA2 mutation treated with a PARP inhibitor.
    Gynecol Oncol · 2018 · PMID 29937315 · NCT04486352

Breast Neoplasms (4)

  • Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study.
    J Clin Oncol · 2024 · PMID 38537155 · NCT04576455
  • UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure.
    Cancer Chemother Pharmacol · 2024 · PMID 38305868 · NCT04576455
  • heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer.
    BMC Cancer · 2024 · PMID 38789924 · NCT05296798
  • Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study.
    Lancet Oncol · 2023 · PMID 37657462 · NCT04436744

Publications by journal

All Giredestrant publications (20)

2024 (3 papers)

  1. Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study.
    Martín M, Lim E, Chavez-MacGregor M, et al. · J Clin Oncol · 2024 · Derived
    PubMed: PMID 38537155 · NCT04576455 · Breast Neoplasms
  2. UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure.
    Malhi V, Nowicka M, Chen YC, et al. · Cancer Chemother Pharmacol · 2024 · Derived
    PubMed: PMID 38305868 · NCT04576455 · Breast Neoplasms
  3. heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer.
    Kuemmel S, Harper-Wynne C, Park YH, et al. · BMC Cancer · 2024 · Derived
    PubMed: PMID 38789924 · NCT05296798 · Breast Neoplasms

2023 (1 paper)

  1. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study.
    Hurvitz SA, Bardia A, Quiroga V, et al. · Lancet Oncol · 2023 · Derived
    PubMed: PMID 37657462 · NCT04436744 · Breast Neoplasms

2019 (3 papers)

  1. Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.
    Westin SN, Sill MW, Coleman RL, et al. · Gynecol Oncol · 2019 · Background
    PubMed: PMID 31623857 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  2. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial.
    Rini BI, Powles T, Atkins MB, et al. · Lancet · 2019 · Background
    PubMed: PMID 31079938 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  3. Correction: A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors.
    Cancer Discov · 2019 · Background
    PubMed: PMID 30385525 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2018 (2 papers)

  1. PARP Inhibitor Upregulates PD-L1 Expression and Enhances Cancer-Associated Immunosuppression.
    Jiao S, Xia W, Yamaguchi H, et al. · Clin Cancer Res · 2018 · Background
    PubMed: PMID 28167507 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  2. Durable response in a woman with recurrent low-grade endometrioid endometrial cancer and a germline BRCA2 mutation treated with a PARP inhibitor.
    Gockley AA, Kolin DL, Awtrey CS, et al. · Gynecol Oncol · 2018 · Background
    PubMed: PMID 29937315 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2017 (4 papers)

  1. Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer.
    Strickland KC, Howitt BE, Shukla SA, et al. · Oncotarget · 2017 · Background
    PubMed: PMID 26871470 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  2. RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.
    Schwartz LH, Seymour L, Litière S, et al. · Eur J Cancer · 2017 · Background
    PubMed: PMID 27237360 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  3. Inhibition of the PI3K/AKT/mTOR Pathway in Solid Tumors.
    LoRusso PM · J Clin Oncol · 2017 · Background
    PubMed: PMID 27621407 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  4. Immunotherapy and patients treated for cancer with microsatellite instability.
    Colle R, Cohen R, Cochereau D, et al. · Bull Cancer · 2017 · Background
    PubMed: PMID 27979364 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2016 (1 paper)

  1. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial.
    Rosenberg JE, Hoffman-Censits J, Powles T, et al. · Lancet · 2016 · Background
    PubMed: PMID 26952546 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2015 (2 papers)

  1. Integrated Akt/PKB signaling in immunomodulation and its potential role in cancer immunotherapy.
    Xue G, Zippelius A, Wicki A, et al. · J Natl Cancer Inst · 2015 · Background
    PubMed: PMID 26071042 · NCT04486352 (EndoMAP) · Endometrial Neoplasms
  2. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency.
    Le DT, Uram JN, Wang H, et al. · N Engl J Med · 2015 · Background
    PubMed: PMID 26028255 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2014 (1 paper)

  1. Anti-tumor activity of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in cultured endometrial carcinoma cells.
    Miyasaka A, Oda K, Ikeda Y, et al. · BMC Cancer · 2014 · Background
    PubMed: PMID 24625059 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2013 (1 paper)

  1. Integrated genomic characterization of endometrial carcinoma.
    Cancer Genome Atlas Research Network, Kandoth C, Schultz N, et al. · Nature · 2013 · Background
    PubMed: PMID 23636398 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

2011 (1 paper)

  1. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study.
    Aghajanian C, Sill MW, Darcy KM, et al. · J Clin Oncol · 2011 · Background
    PubMed: PMID 21537039 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

1976 (1 paper)

  1. [Extraction of peripherally located bronchial foreign bodies using a x-ray picture amplifier with a television loop].
    Rous J, Rems J, Cermák Z, et al. · Cesk Otolaryngol · 1976 · Background
    PubMed: PMID 1204078 · NCT04486352 (EndoMAP) · Endometrial Neoplasms

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).