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| Overall Recruitment Status: Active, enrollment completed |
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| Official Title |
| EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator’s Choice of Endocrine Therapy, in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
| JZLC |
1762658 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
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| Purpose |
| This study is being done to see how safe an investigational drug is and how well it will work to help people with estrogen receptor positive (ER+), HER2 negative (HER2-) locally advanced or metastatic breast cancer previously treated with endocrine therapy.
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| Detailed Description |
| MBER-3 is a Phase 3 global, randomized, open-label study for patients with ER+, HER2- locally advanced (not amenable to curative treatment by surgery) or mBC, who have been treated with an AI, alone or in combination with a CDK4/6 inhibitor. Approximately 500 patients will be randomized 1:1 between 2 treatment arms (Arm A: Arm B) and will be treated until disease progression or other discontinuation criteria are met. |
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| Gender |
Age Limit |
| Male & Female |
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- 1. Participant must be at least 18 years of age
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2. Have a diagnosis of ER+, HER2- breast cancer
3. Have locally advanced (not amenable to curative treatment by surgery) or metastatic disease and fulfill 1 of the following criteria:
a. relapsed with evidence of progression while on or within 12 months of completion of (neo)adjuvant AI, alone or in combination with a CDK4/6 inhibitor, with no treatment for advanced disease
b. relapsed with evidence of progression >12 months from completion of (neo)adjuvant ET, with subsequent progression on or after only 1 line of therapy with an AI, alone or in combination with a CDK4/6 inhibitor. Patients may not have received any other prior therapy (other than the aforementioned: AI, alone or in combination with a CDK4/6 inhibitor) in the advanced/metastatic setting
c. presented de novo with metastatic disease, with subsequent progression on or after only 1 line of therapy with an AI, alone or in combination with a CDK4/6 inhibitor.
Patients may not have received any other prior therapy (other than the
aforementioned: AI, alone or in combination with a CDK4/6 inhibitor) in the advanced/metastatic setting
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4. Must be deemed appropriate for treatment with ET
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- 15. Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR-, or AKT-inhibitor
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16. Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
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17. Have inflammatory breast cancer
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18. Patients with known pathogenic germline mutations who are appropriate for treatment with a PARP inhibitor, in regions where these therapies are approved and available, are not eligible for this study
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19. Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies,
and rapid progression of the disease
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20. Have symptomatic or untreated brain metastasis. Patients with treated brain metastases are eligible for this study if they completed prior therapy (including radiation and/or surgery) =28 days prior to first dose of study treatment and are not receiving corticosteroids and/oranticonvulsants for at least 14 days prior to first dose of study treatment, and their disease is asymptomatic and radiographically stable for at least 28 days prior to consent by repeat imaging (repeat imaging should be performed during study screening)
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