^
    19d
    A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) (clinicaltrials.gov)
    P3, N=4170, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jan 2035 --> Sep 2033
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    tamoxifen • giredestrant (RG6171)
    21d
    Giredestrant immobilizes the estrogen receptor to exert potent antitumor efficacy against ER-active breast cancers. (PubMed, Cell Chem Biol)
    Giredestrant redistributes enhancers, decreasing the expression of estrogen-induced genes and inducing the expression of putative tumor suppressors. These molecular data, together with results from recent trials, rationalize giredestrant's potential to serve as an optimized endocrine backbone for ER+ breast cancer.
    Journal
    |
    ER (Estrogen receptor)
    |
    giredestrant (RG6171)
    26d
    GO39932: A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer (clinicaltrials.gov)
    P1, N=181, Active, not recruiting, Genentech, Inc. | Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • triptorelin • goserelin acetate • giredestrant (RG6171)
    2ms
    A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer) (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Genentech, Inc.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    giredestrant (RG6171)
    2ms
    Loss of luminal lineage drives resistance to next-generation ERα antagonists in pretreated ER+ HER2- locally-advanced or metastatic breast cancer. (PubMed, Nat Commun)
    In recent clinical trials of metastatic ER+ BC, next-generation SERDs demonstrated clinical activity, and elacestrant received an approval for advanced ESR1-mutant disease. NR tumors instead up-regulate multiple ERα-independent proliferative pathways, such as EGFR/MAPK and Hippo/TEAD, which may represent targetable dependencies in NR disease. Modeling resistance and lineage plasticity in vitro, we find that giredestrant-resistant ER+ BC cell lines exhibit profound shifts in chromatin accessibility, with the transcription factors, FOXA1 and FOXM1, implicated in gene expression of NR-upregulated proliferative pathways.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FOXA1 (Forkhead Box A1) • FOXM1 (Forkhead Box M1)
    |
    ER positive • HER-2 negative • ESR1 mutation
    |
    Orserdu (elacestrant) • giredestrant (RG6171)
    3ms
    ctDNA and tumor-based biomarkers of giredestrant response in acelERA breast cancer. (PubMed, Nat Commun)
    Furthermore, early ctDNA clearance identifies responding patients, and the combination of low ER activity and high ctDNA burden predicts rapid clinical progression. These findings provide a framework for personalizing future breast cancer therapies by integrating liquid biopsies with tissue-based signatures.
    Journal • Circulating tumor DNA
    |
    ER (Estrogen receptor)
    |
    ER positive • ESR1 mutation
    |
    giredestrant (RG6171)
    3ms
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=976, Recruiting, MedSIR | Trial completion date: Dec 2028 --> Jun 2028 | Trial primary completion date: Dec 2028 --> Jun 2028
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • MammaPrint®
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    4ms
    A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) (clinicaltrials.gov)
    P3, N=4170, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Mar 2026 --> Aug 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    tamoxifen • giredestrant (RG6171)
    4ms
    MedOPP485: A proof of concept study to evaluate treatmentsefficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer population (2023-505661-89-00`2022-002616-24)
    P1/2, N=1071, Recruiting, Medica Scientia Innovation Research S.L.
    New P1/2 trial • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    therascreen® PIK3CA RGQ PCR Kit
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    4ms
    GO46021: To compare the Safety and activity of GDC-4198 Alone and in Combination with Giredestrant against Abemaciclib and Giredestrant in Participants with Breast Cancer (2025-521128-31-00)
    P1/2, N=73, Recruiting, Genentech Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Verzenio (abemaciclib) • giredestrant (RG6171) • RG6794
    4ms
    A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer (clinicaltrials.gov)
    P1/2, N=285, Recruiting, Genentech, Inc. | Trial completion date: Jul 2030 --> Aug 2028 | Trial primary completion date: Jul 2030 --> Aug 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • giredestrant (RG6171) • RG6794
    4ms
    A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (clinicaltrials.gov)
    P1, N=136, Recruiting, Genentech, Inc. | Trial completion date: Jul 2029 --> Apr 2030 | Trial primary completion date: Jul 2029 --> Apr 2030
    Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    giredestrant (RG6171) • omeprazole