Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04293393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-19
First Post:
2020-02-28
Brief Title:
Neoadjuvant Study Chemotherapy vs Letrozole Abemaciclib in HRHER2- HighIntermediate Risk Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase II Randomized Open-label International Multicenter Study to Compare Efficacy of Standard Chemotherapy vs Letrozole Plus Abemaciclib as Neoadjuvant Therapy in HR-positiveHER2-negative HighIntermediate Risk Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
CARABELA
Brief Summary:
Phase II randomized open-label international multicenter study to compare efficacy of standard chemotherapy vs letrozole plus abemaciclib as neoadjuvant therapy in HR-positiveHER2-negative highintermediate risk breast cancer patients
Detailed Description:
This is an international multicenter open-label randomized phase II study in the neoadjuvant setting
Approximately 200 premenopausal and postmenopausal women with Hormone Receptor HR-positiveHuman Epidermal Growth Factor Receptor 2 HER2 negative Breast Cancer BC of intermediatehigh risk determined by Ki67 index 20 on untreated breast tissue and centrally assessed with indication of neoadjuvant treatment will be included Patients with Early Breast Cancer EBC on stages II-III tumor size T 2cm - T3 T4b and lymph node involvement N N0-2 according to the 8th edition of the Union for International Cancer Control UICC TNM Classification The subgroup with tumors T2 N0 will include high risk patients based on Ki67 index 30 or Ki67 index between 20 and 30 and Progesterone Receptor PgR negative andor histological grade 3
Patients will be stratified according to the disease stage II vs III menopausal status premenopausal vs postmenopausal and Ki67 index Ki67 30 vs Ki67 30
Once the screening process locally at site and at the central laboratory is completed fully eligible patients will be randomized in a 11 fashion to the control arm with standard Chemotherapy CT based on anthracyclines and taxanes or to the experimental arm with letrozole abemaciclib
All patients will be treated according to the stipulations below unless any of the following occur unacceptable toxicity progressive disease or withdrawal of informed consent whatever occurs first
After the last dose of any of the drugs in the neoadjuvant combinations in both treatment arms definitive surgery will be performed For Arm A not earlier than 21 days and not later than 42 days after the last dose of chemotherapy and for Arm B within 7 days from the last dose of abemaciclib andor letrozole unless toxicities are not recovered completely in any treatment arm
Approximately 200 premenopausal and postmenopausal women with Hormone Receptor HR-positiveHuman Epidermal Growth Factor Receptor 2 HER2 negative Breast Cancer BC of intermediatehigh risk determined by Ki67 index 20 on untreated breast tissue and centrally assessed with indication of neoadjuvant treatment will be included Patients with Early Breast Cancer EBC on stages II-III tumor size T 2cm - T3 T4b and lymph node involvement N N0-2 according to the 8th edition of the Union for International Cancer Control UICC TNM Classification The subgroup with tumors T2 N0 will include high risk patients based on Ki67 index 30 or Ki67 index between 20 and 30 and Progesterone Receptor PgR negative andor histological grade 3
Patients will be stratified according to the disease stage II vs III menopausal status premenopausal vs postmenopausal and Ki67 index Ki67 30 vs Ki67 30
Once the screening process locally at site and at the central laboratory is completed fully eligible patients will be randomized in a 11 fashion to the control arm with standard Chemotherapy CT based on anthracyclines and taxanes or to the experimental arm with letrozole abemaciclib
All patients will be treated according to the stipulations below unless any of the following occur unacceptable toxicity progressive disease or withdrawal of informed consent whatever occurs first
After the last dose of any of the drugs in the neoadjuvant combinations in both treatment arms definitive surgery will be performed For Arm A not earlier than 21 days and not later than 42 days after the last dose of chemotherapy and for Arm B within 7 days from the last dose of abemaciclib andor letrozole unless toxicities are not recovered completely in any treatment arm
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002123-15 | EUDRACT_NUMBER | None | None |