Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05954442
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-07-13
Brief Title:
Everolimus With Investigators Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer TNBC With Luminal Androgen Receptor LAR Subtype
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
An Open Randomized Phase III Study of Everolimus With Investigators Choice of Chemotherapy Versus Chemotherapy in The First-Line Treatment of Luminal Androgen Receptor LAR Subtype With PI3KAKTmTOR Pathway Mutation of Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer BCTOP-T-M03
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCTOP-T-M03
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of investigators choice of chemotherapy either alone or in combination with everolimus in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer luminal androgen receptor LAR subtype with PI3KAKTmTOR PAM pathway mutation as the first-line treatment
Detailed Description:
Eligible participants will be those diagnosed with estrogen receptor ER-negative Immunohistochemistry IHC ER positive 1 progesterone receptor PR negativeIHC PR positive 1 and human epidermal growth factor receptor 2 HER2-negative IHC 0 or or IHC Fluorescence in situ hybridization FISH - LAR subtype with PAM pathway mutation locally recurrent inoperable or metastatic breast cancer who have received no prior chemotherapy targeted therapy or other treatments
The study is aimed to evaluate the efficacy of investigators choice ICC of chemotherapy nab-paclitaxel capecitabine eribulin carboplatin vinorelbine or utidelone either alone or in combination with everolimus This study aims to see if everolimus plus chemotherapy allows patients to live longer without the cancer getting worse or simply to live longer compared to patients receiving investigators choice of chemotherapy This study is also looking to see how the treatment and the cancer affects patients quality of life
The study is aimed to evaluate the efficacy of investigators choice ICC of chemotherapy nab-paclitaxel capecitabine eribulin carboplatin vinorelbine or utidelone either alone or in combination with everolimus This study aims to see if everolimus plus chemotherapy allows patients to live longer without the cancer getting worse or simply to live longer compared to patients receiving investigators choice of chemotherapy This study is also looking to see how the treatment and the cancer affects patients quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None