^
    1d
    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 Cancer Prognostic Gene Signature Assay • MammaPrint®
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    15d
    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)
    16d
    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)
    18d
    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
    22d
    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
    30d
    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
    1m
    ZG005 combination hydrochloride gilteritinib tablets in patients with relapsed or refractory lymphoma: a multicentre, open-label, dose-exploration and dose-expansion phase I/II clinical study. (ChiCTR2500114728)
    P1/2, N=60, Recruiting, The First Affiliated Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Zhejiang University School of Medicine
    New P1/2 trial
    |
    Xospata (gilteritinib) • giredestrant (RG6171) • nilvanstomig (ZG005) • ravoxertinib (RG7842)
    1m
    Optimizing dose selection in oncology: the rationale for the clinical dose selection of giredestrant, an oral selective estrogen receptor degrader. (PubMed, Expert Opin Investig Drugs)
    Data were leveraged from preclinical and phase I/II studies in metastatic and early breast cancer, as a single agent and with palbociclib, to inform giredestrant dose selection. Our learnings challenge the MTD paradigm in drug development, particularly in targeted therapies, and demonstrate the importance of basing dose selection on the totality of evidence, including preclinical data, and may help inform the clinical development of future targeted therapies.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Ibrance (palbociclib) • giredestrant (RG6171)
    2ms
    PREcoopERA: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer (clinicaltrials.gov)
    P2, N=231, Completed, ETOP IBCSG Partners Foundation | Recruiting --> Completed | Trial completion date: Jun 2026 --> Sep 2025 | Trial primary completion date: Jun 2026 --> Sep 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    anastrozole • triptorelin • giredestrant (RG6171)
    2ms
    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. | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    giredestrant (RG6171) • omeprazole
    2ms
    Selective Estrogen Receptor Degraders Induce Bradycardia by Modulating Nuclear Estrogen Signaling. (PubMed, JACC Basic Transl Sci)
    Giredestrant and camizestrant induced significant bradycardia in wild-type zebrafish embryos, whereas fulvestrant and amcenestrant (SERDs that do not induce bradycardia in patients) did not alter heart rate. Mutations in gper, esr2a, and esr2b did not confer resistance to SERD-induced bradycardia, whereas esr1 mutant embryos were protected. These findings demonstrate that SERD-associated bradycardia is mediated through Esr1 signaling, supporting an on-target adverse effect.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive • BRAF wild-type • ESR1 mutation
    |
    fulvestrant • amcenestrant (SAR439859) • camizestrant (AZD9833) • giredestrant (RG6171)
    2ms
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=1260, Recruiting, MedSIR | Active, not recruiting --> Recruiting
    Enrollment open • 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
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)