A Phase 3 interventional study of GB491+ Fulvestrant and Placebo+Fulvestrant in Locally Advanced or Metastatic Breast Cancer, sponsored by Genor Biopharma Co., Ltd.. Completed at 54 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Genor Biopharma Co., Ltd. (part of Edding Genor Group Holdings Limited) · Phase 3, Interventional, and Treatment
GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 275 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Genor Biopharma Co., Ltd. is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
First submitted before Genor Biopharma Co., Ltd. became part of Edding Genor Group Holdings Limited.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
1) Prior endocrine adjuvant therapy: a) Radiologic evidence of progressive disease (PD) during or within 12 months following (neo)adjuvant therapy with an aromatase inhibitor (AI) or an anti-estrogen such as tamoxifen, and no subsequent endocrine therapy for locally advanced or metastatic breast cancer; b) Radiologic evidence of PD during or within 12 months following (neo)adjuvant therapy with an AI or an anti-estrogen such as tamoxifen, after receiving the first-line endocrine therapy for locally advanced or metastatic breast cancer, and who developed radiologically documented PD after receiving therapy for ≥ 6 months; c) Radiologically documented PD more than 12 months following the end of adjuvant therapy with AIs or anti-estrogens such as tamoxifen, followed by radiographic progression following first-line therapy with AIs or anti-estrogens for locally advanced or metastatic breast cancer; 2) Progression with radiographic evidence of disease following prior first-line endocrine therapy for locally advanced or metastatic breast cancer in subjects who have not received prior (neo) adjuvant therapy; 3) Prior chemotherapy: In addition to endocrine therapy, subjects are eligible if they received a maximum of 1 prior line of chemotherapy for locally advanced or metastatic breast cancer and discontinued treatment for at least 28 days prior to randomization; 7.According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If there is no measurable lesion, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI 8.ECOG performance status of 0 or 1 9.Adequate organ and marrow function.
Key Exclusion Criteria:
Drug: GB491+ Fulvestrant
Drug: Placebo+Fulvestrant
Drug pages: Lerociclib · Fulvestrant
GB491: The dose of GB491 is 150 mg, BID, which should be taken with a meal. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial. Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Also known as: test drug + Fulvestrant
Placebo: The dose of Placebo is 150 mg, BID, which should be taken with a meal. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial. Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.
Also known as: placebo control + Fulvestrant
PFS assessed by the investigator
To assess the PFS assessed by the investigator
Time frame: Approximately 1.5 years
PFS assessed by the blinded independent central review (BICR)
To assess the PFS assessed by the BICR
Time frame: Approximately 1.5 years
OS
To assess the overall survival (OS)
Time frame: Approximately 3 years
ORR
To assess the objective response rate (ORR)
Time frame: Approximately 1.5 years
DOR
To assess the duration of response
Time frame: Approximately 1.5 years
DCR
To assess the disease control rate
Time frame: Approximately 1.5 years
CBR
To assess the clinical benefit rate
Time frame: Approximately 1.5 years
Safety and tolerability
To assess the safety and tolerability assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs) according to NCI-CTCAE version 5.0
Time frame: Approximately 3 years
PK
To assess the PK assessed by population pharmacokinetic analysis based on plasma concentrations of GB491
Time frame: From Cycle 1 to Cycle 4, approximately 4 months
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lerociclib · Fulvestrant