Ignite Creation Date:
2024-05-06 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03373708
Status:
UNKNOWN
Last Update Posted:
2017-12-18
First Post:
2017-12-11
Brief Title:
Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
Sponsor:
Zhiyong Yu
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
NOT_YET_RECRUITING
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:
Breast cancer is the most common female malignancy in the world and the leading cause of cancer-associated mortalities among women Hormone receptors HR including ER and PR are the main prognostic factor for breast cancer patients Breast cancer subtype was defined by ER PR HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer Breast cancer which ER are positive have less aggressive and better long-term prognoses than other breast cancer subtype Luminal B1 was definited as ER Positive PR positive 20 or Ki-67 20 and HER2-Negative Although standard therapy to HR positive breast cancer is endocrine treatment evidence reported that Luminal B1 breast cancers with lower PR expression are less sensitive to tamoxifen than luminal A breast cancers with higher PR expression and the specific mechanism is not clear We previously had a clinically analysed and we found the Luminal B1 breast cancer had a significant proportion with 38 Whether we need standard chemotherapy or chemotherapy based intensive endocrine therapy for those patients In our research we divided the patients with ER positive PR negative and HER-2 negative into two groups One groups will be treated with 8 cycles of chemotherapy EC4-T4 The other received 4 cycles of chemotherapy TC4 then will be given the intensive endocrine therapy Goserelin acetateTamoxifen for young patientsLetrozole for postmenopausal patients The primary endpoint is to assess disease-free survival DFS and overall survival OS in different regiments the secondary endpoint is to assess the expression of female hormone levels The correlation of the expression of female hormone levels with the clinical outcomes so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer
Detailed Description:
The trial is designed to investigative the risk and clinical benefit of chemotherapy and intensive endocrine therapy for Luminal B1 early-staged breast cancer In this trial the investigators will randomly assign 200 primary breast cancer patients to receive four cycles of epirubicin and cyclophosphamide EC followed by four cycles of docetaxelT or four cycles of docetaxel and cyclophosphamide TC followed by intensive endocrine therapy Goserelin acetateTamoxifenLetrozole for young patients Patients with HER-2 positive was excluded The patients conditions will be assessed before and after every four cycles of adjuvant chemotherapy to determine if there is any progression of the disease The patients conditions will be assessed every three months when they received the intensive endocrine therapy Goserelin acetateTamoxifen for young patientsLetrozole for postmenopausal patients Patients will be followed up for DFS and OS in different regiments the secondary endpoint is to assess the expression of female hormone levels The correlation of the expression of female hormone levels with the clinical outcomes so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer
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