GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    270
  • sponsor
    Genor Biopharma Co., Ltd.
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Updated on 30 June 2022
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Summary

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.

Details
Condition Locally Advanced or Metastatic Breast Cancer
Treatment GB491+ Fulvestrant, Placebo+Fulvestrant
Clinical Study IdentifierNCT05054751
SponsorGenor Biopharma Co., Ltd.
Last Modified on30 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Females or males of 18 years of age or older at study screening
Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
The subject has been diagnosed with ER-positive breast cancer in the local laboratory
Subject has HER2-negative breast cancer in the local laboratory
Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
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 only bone metastases are present, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI
ECOG performance status of 0 or 1
Adequate organ and marrow function

Exclusion Criteria

Previous treatment with fulvestrant, everolimus and any other CDK4/6 inhibitors
Subjects with known hypersensitivity to any component of GB491 or Fulvestrant
Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
Visceral crisis
Patients with skin lesion only and radiographically non-measurable at baseline
Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 14 days prior to randomization
Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
Subjects use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
Patients with long-term systematic use of corticosteroids
Any severe and/or uncontrollable medical conditions
Patients with severely impaired lung function
Known history of HIV infection or history of HIV seropositivity
Subjects have significant hepatic disease
Coagulation abnormalities
Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years
Lactating women
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