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Locally Advanced or Metastatic Breast CancerPhase 3NCT05054751

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

A Phase 3 study testing GB491+ Fulvestrant in people with Locally Advanced or Metastatic Breast Cancer, run by Genor Biopharma Co., Ltd. at 54 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GB491+ Fulvestrant
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
54 sitesChina
Study dates
10 Sep 2021to 30 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females or males of 18 years of age or older and less than 75 years of age at study screening
  • Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
  • Patients have been diagnosed with ER-positive breast cancer in the local laboratory
  • Patents have been diagnosed with HER2-negative breast cancer in the local laboratory
  • Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
  • Prior endocrine therapy and chemotherapy, the following are permitted:
  • 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.

Who cannot join

  • Previous treatment with fulvestrant, everolimus or any other CDK4/6 inhibitors
  • Patients 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
Show all 14Show fewer
  • Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 7 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
  • Patients 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
  • Patients have significant hepatic disease

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

China54 sites

  • Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Cancer hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • Beijing Tiantan Hospital , Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Bethune First Hospital Of Jilin University

    Changchun, Jillin, 130061

  • West China School of Medicine

    Chengdu, Sichuan, 610044

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • Chognqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • The First people's hospital of Foshan

    Foshan, Guangdong, 528000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangdong provincial TCM hospital

    Guangzhou, Guangdong, 510120

  • Harbin Medcial Univercity cancer hospital

    Haerbin, Heilongjiang, 150081

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The Affiliated hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 750306

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250013

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250013

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Affiliated hospital of Jining Medical University

    Jining, Shandong, 272007

  • The Third Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650118

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252004

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • Jiangxi Provincial Hospital

    Nanchang, Jiangxi, 330029

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Hainan Third People's Hospital

    Sanya, Hainan, 572000

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200030

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • Liaoning Cancer hospital & Institute

    Shenyang, Liaoning, 110801

  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital

    Shenzhen, Guangdong, 518172

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50011

  • Affiliated hospital of Hebei University

    Shijiazhuang, Hebei, 500311

  • Taian City Central Hospital

    Taian, Shandong, 271099

  • The first hospital of Shanxi Medical University

    Taiyuan, Shanxi, 003001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300181

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

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.

Being tested
GB491+ Fulvestrant, Placebo+Fulvestrant
Keywords
CDK4/6, Phase III, GB491
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB491+ FulvestrantDrug

    Also called test drug + 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.

  • Placebo+FulvestrantDrug

    Also called placebo control + 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.

Study groups in NCT05054751
Study groupRoleWhat they receive
GB491+ FulvestrantExperimentalNot described
Receives: Drug: GB491+ Fulvestrant
Placebo+FulvestrantPlacebo comparatorNot described
Receives: Drug: Placebo+Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS assessed by the investigator

    To assess the PFS assessed by the investigator

    Measured: Approximately 1.5 years

Secondary outcomes (8)

  1. PFS assessed by the blinded independent central review (BICR)

    To assess the PFS assessed by the BICR

    Measured: Approximately 1.5 years

  2. OS

    To assess the overall survival (OS)

    Measured: Approximately 3 years

  3. ORR

    To assess the objective response rate (ORR)

    Measured: Approximately 1.5 years

  4. DOR

    To assess the duration of response

    Measured: Approximately 1.5 years

  5. DCR

    To assess the disease control rate

    Measured: Approximately 1.5 years

  6. CBR

    To assess the clinical benefit rate

    Measured: Approximately 1.5 years

  7. 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

    Measured: Approximately 3 years

  8. PK

    To assess the PK assessed by population pharmacokinetic analysis based on plasma concentrations of GB491

    Measured: From Cycle 1 to Cycle 4, approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start10 Sep 2021
  3. Primary completion2 Dec 2022
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054751
Sponsor's protocol ID
GB491-004
Status last verified
Aug 2021
First submitted
13 Aug 2021
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu B, Zhang Q, Luo Y, Tong Z, Sun T, Shan C, Liu X, Yao Y, Zhao B, Wang S, Zeng X, Hu C, Yan X, Wang X, Jia H, Chen Z, Qiu F, Wu X, Zhang D, Li T. Lerociclib plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy: LEONARDA-1 a phase III randomized trial. Nat Commun. 2025 Jan 16;16(1):716. doi: 10.1038/s41467-025-56096-2.

    PubMed 39820749

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GB491+ Fulvestrant in people with Locally Advanced or Metastatic Breast Cancer, run by Genor Biopharma Co., Ltd. at 54 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by the investigator (time frame: Approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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