Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01057069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-12
First Post:
2010-01-26
Brief Title:
Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Randomized Phase IIIII Study of Individualized Neoadjuvant Chemotherapy in Triple Negative Breast Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-10
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:
neo-TN
Brief Summary:
This study aims to compare the response of triple-negative breast cancer with deficient homologous recombination to intensified alkylating chemotherapy versus standard chemotherapy with dose dense AC andor Docetaxel-Capecitabine
Detailed Description:
Homologous Recombination HR is a DNA repair mechanism that can repair double-strand DNA breaks It is the only reliable repair mechanism that can repair the consequences of DNA adducts caused by bifunctional alkylating agents such as cyclophosphamide thiotepa or carboplatin Alternative DNA repair mechanisms exist but these unavoidably induce DNA mutations deletions and chromosome aberrations giving give rise to genetic instability HRD may be a consequence of inactivation of the BRCA-1 or BRCA-2 genes as in hereditary breast cancer but it may also be caused by defects in the Fanconi anemia pathway or by amplification of the EMSY gene HRD is present in breast cancer cells but not in healthy cells of BRCA-1 or BRCA-2 mutation carriers and also in about half of the sporadic triple-negative breast cancers
This phase IIIII controlled multicenter trial will investigate the ability of individualized chemotherapy to improve the objective response rate of triple-negative breast cancer estrogen receptor and progesterone receptor-negative no HER2 amplification to preoperative neoadjuvant chemotherapy It will answer the question whether intensified alkylating chemotherapy improves the response rate of tumors with a Homologous Recombination Defect HRD and it will gather data required for the design of a phase III study documenting the efficacy of response monitoring by contrast-enhanced MRI in TN breast cancer without HRD
This phase IIIII controlled multicenter trial will investigate the ability of individualized chemotherapy to improve the objective response rate of triple-negative breast cancer estrogen receptor and progesterone receptor-negative no HER2 amplification to preoperative neoadjuvant chemotherapy It will answer the question whether intensified alkylating chemotherapy improves the response rate of tumors with a Homologous Recombination Defect HRD and it will gather data required for the design of a phase III study documenting the efficacy of response monitoring by contrast-enhanced MRI in TN breast cancer without HRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-015238-31 | EUDRACT_NUMBER | None | None |