Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02767661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2016-05-07
Brief Title:
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR Her2- Metastatic Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase 3 Randomized Controlled Study of Metronomic Capecitabine Combined With Aromatase Inhibitor Versus Aromatase Inhibitor Alone for First Line Treatment in Hormone Receptor-positive Her2-negative Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
MECCA
Brief Summary:
The study is designed to compare the clinical benefit following treatment with aromatase inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in women with hormone receptor-positive Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their advancedmetastatic disease
Detailed Description:
Initial endocrine therapy ET is a common choice for hormone receptor positive HR HER2 negative HER2- metastatic breast cancer MBC patients for its good tolerability low toxicity and durable response The median time to progression TTP of initial ET in HR HER2- metastatic patients is about 9 months with aromatase inhibitors AIs However all metastatic patients receiving ET will develop resistance to the conventional endocrine treatments ultimately So some novel agents like palbociclib and everolimus are approved to be effective in improving the efficacy of standard ET But the fact we have to face is either palbociclib or everolimus is focusing on a single checkpoint of pathway that responsible for resistance of ET In clinical there are some patients without an activation of resistance-related pathways have poor response to endocrine therapy And the mechanisms of resistance to endocrine therapy is complicated and not fully understood So far these novel agents have not completely solved the clinical problems of secondary drug-resistance Maybe a broad spectrum anti-cancer therapy with low toxicity and good tolerability is more practical and promising in the near future Metronomic chemotherapy is administration of low-dose chemotherapy to induce disease control in metastatic cancer patients which has low-incidence of adverse effects More and more evidences showed activity of metronomic therapy in breast cancer Metronomic therapy with or without endocrine therapy in both metastatic and neoadjuvant setting showed considerable efficacy Although the concept of combination of chemotherapy and endocrine therapy simultaneously was large abandoned because of previous using tamoxifen and intravenous chemotherapy showing no additional benefit with better understanding of the biology of endocrine therapy and metronomic chemotherapy its worth to evaluate whether endocrine therapy plus low-dose metronomic chemotherapy brings a better clinical benefit rate without sacrificing the quality of patients life In this phase III study we investigate the efficacy and safety of low-dose capecitabine plus AI to treat metastatic HR HER2- postmenopausal breast cancer patients
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