Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04113863
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2019-06-26
Brief Title:
Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
A Randomized Phase 2 Clinical Trial to Evaluate the Activity of ATRA in Combination With Anastrozole in Pre-operative Phase of Operable HR-positiveHER2-negative Early Breast Cancer ATRA
Status:
RECRUITING
Status Verified Date:
2023-10
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:
ATRA
Brief Summary:
This is an Italian single center randomized phase II study ATRA all-trans retinoic acid and derivatives retinoids are promising anticancer agents and exert their anti-proliferative differentiating and apoptotic effects through the nuclear retinoic acid receptors including RARĪ± retinoic acid receptor alpha Although the clinical use of ATRA in haematological malignancies Acute Promyelocytic Leukemia APL is well established its use in solid tumors is limited However some recent pre-clinical evidence suggests a possible role of ATRA in the treatment of specific subtypes of HR-positive Hormonal ReceptorHER2-negative early breast cancer eBC
Moving from pre-clinical evidence and given the well-known retinoid mechanism of action The hypotheses is that ATRA contributes to tumor regression in a specific sub-population of eBCs Using a preoperative window-of-opportunity model aimed at testing the activity of ATRA in combination with anastrozole in postmenopausal women with newly diagnosed resectable HRHER2- eBCs
Moving from pre-clinical evidence and given the well-known retinoid mechanism of action The hypotheses is that ATRA contributes to tumor regression in a specific sub-population of eBCs Using a preoperative window-of-opportunity model aimed at testing the activity of ATRA in combination with anastrozole in postmenopausal women with newly diagnosed resectable HRHER2- eBCs
Detailed Description:
This is an Italian single center randomized phase II study ATRA all-trans retinoic acid and derivatives retinoids are promising anticancer agents and exert their anti-proliferative differentiating and apoptotic effects through the nuclear retinoic acid receptors including RARĪ± retinoic acid receptor alpha Although the clinical use of ATRA in haematological malignancies Acute Promyelocytic Leukemia APL is well established its use in solid tumors is limited However some recent pre-clinical evidence suggests a possible role of ATRA in the treatment of specific subtypes of HR-positive Hormonal ReceptorHER2-negative early breast cancer eBC
This is a prospective randomized Phase 2 window-of opportunity pre-operative clinical trial to study the activity of ATRA in combination with anastrozole in HRHER2- eBCs All patients will receive primary treatment with anastrozole po intended as standard of care and will be randomized to add or not ATRA po Patients will receive study treatments by continuous once-daily administration for a period of 4 weeks before definitive surgery Treatment will start 28 days before the scheduled surgical resection and will be completed at the time of surgery scheduled no more than 1 week after completion of the study treatment The interval between diagnostic core biopsy baseline clinical evaluation and study entry must be no more than 4 weeks
The study will compare the anti-tumor activity of the treatments in the two arms ATRAanastrozole or Aa vs anastrozole alone or a In this comparison the primary outcome measure is the proportion of complete BC cells cycle arrest defined as Ki67 27 as previously reported Indeed the responder patients will be defined according the achievement of an absolute value of Ki67 27 because of its predictive value on relapse-free survival The study aims at demonstrating that the ATRAanastrozole Aa arm is characterized by significant therapeutic superiority over the anastrozole a arm
Clinical and ultrasound examinations trascriptome analysis on formalin-fixed paraffin-embedded FFPE samples will be performed at baseline and at the time of definitive surgery
This is a prospective randomized Phase 2 window-of opportunity pre-operative clinical trial to study the activity of ATRA in combination with anastrozole in HRHER2- eBCs All patients will receive primary treatment with anastrozole po intended as standard of care and will be randomized to add or not ATRA po Patients will receive study treatments by continuous once-daily administration for a period of 4 weeks before definitive surgery Treatment will start 28 days before the scheduled surgical resection and will be completed at the time of surgery scheduled no more than 1 week after completion of the study treatment The interval between diagnostic core biopsy baseline clinical evaluation and study entry must be no more than 4 weeks
The study will compare the anti-tumor activity of the treatments in the two arms ATRAanastrozole or Aa vs anastrozole alone or a In this comparison the primary outcome measure is the proportion of complete BC cells cycle arrest defined as Ki67 27 as previously reported Indeed the responder patients will be defined according the achievement of an absolute value of Ki67 27 because of its predictive value on relapse-free survival The study aims at demonstrating that the ATRAanastrozole Aa arm is characterized by significant therapeutic superiority over the anastrozole a arm
Clinical and ultrasound examinations trascriptome analysis on formalin-fixed paraffin-embedded FFPE samples will be performed at baseline and at the time of definitive surgery
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