Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05212454
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2022-01-15
Brief Title:
Efficacy of Supplement Adjuvant Capecitabine in HRHER2- Breast Cancer Patients With High Risks
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor HR-Positive Human Epidermal Growth Factor Receptor 2 HER2-Negative High-risk Breast Cancer Patients a Multicenter Single-arm Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
According to the latest data from the World Health Organizations International Agency for Research on Cancer IARC for 2020 breast cancer has been the most prevalent cancer with 226 million new cases Among Chinese breast cancer patients approximately 60 are hormone receptor HR positive and 80 have early-stage breast cancer For HR-positive human epidermal growth factor receptor-2 HER2 negative breast cancer patients the first peak of recurrence is about 2-3 years after surgery especially for patients with high-risk clinical andor pathological features Therefore adjuvant therapy is essential to reduce recurrence during this period
Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil 5-Fu in vivo Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer Therefore we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors
This trial is an open single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors
Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil 5-Fu in vivo Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer Therefore we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors
This trial is an open single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors
Detailed Description:
None
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