Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02095184
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2014-03-20
Brief Title:
GCC 1366 Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
GCC 1366 A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors to Evaluate Anti-Proliferative Response in Obese and Overweight Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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:
More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors AIs AIs are drugs that stop female hormone production This hormone production mostly happens in fat muscle and breast tissue in postmenopausal women The female hormone estrogen is an important hormone for the growth of breast cancer cells Anastrozole Arimidex and Letrozole Femara are AIs that are approved by the Food and Drug Administration FDA They have been used since 2005 to treat women with early stage breast cancer
When given before surgery neoadjuvant both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients In over 50 of patients anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes On top of that whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy
One of the things may influence the level of hormone is body weight It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer This is likely due to an increase in aromatase activity in the fatty tissue However at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight Currently we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat
The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat
When given before surgery neoadjuvant both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients In over 50 of patients anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes On top of that whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy
One of the things may influence the level of hormone is body weight It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer This is likely due to an increase in aromatase activity in the fatty tissue However at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight Currently we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat
The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat
Detailed Description:
GCC 1366 is a prospective randomized window trial to evaluate the anti-proliferative response in obese and overweight breast cancer patients treated with neoadjuvant non-steroidal aromatase inhibitors Post-menopausal women over the age of 18 years with estrogen receptor positive Her 2 neu negative stage II-III breast cancer are eligible Participants will be randomized according to BMI to neoadjuvant treatment with Arimidex or Letrozole
A total of 90 patients will be enrolled with 15 patients in each cohort below
Cohort 1 Patients with BMI 250 kgm2 treating with anastrozole
Cohort 2 Patients with BMI 250-299 kgm2 treating with anastrozole
Cohort 3 Patients with BMI 30 kgm2 treating with anastrozole
Cohort 4 Patients with BMI 250 kgm2 treating with letrozole
Cohort 5 Patients with BMI 250-299 kgm2 treating with letrozole
Cohort 6 Patients with BMI 30 kgm2 treating with letrozole
Based on the patients calculated BMI patients in each BMI category normal overweight and obese will be enrolled in the different cohorts as described above The first 15 patients in each BMI category will be treated with anastrozole After completion of enrollment in cohorts 1 2 and 3 subsequent patients will be treated with letrozole in cohorts 4 5 and 6
Anastrozole 1 mg or Letrozole 25 mg oral daily will be administered and continued for a minimum of 14 days and a maximum of 28 days 2-4 weeks Surgery will be performed between weeks 2-3 of treatment unless there are compelling medical or personal reasons that prevent a patient from having surgery during this time In those cases patients may continue anastrozole or letrozole up to 4 weeks before surgery Surgery should be performed within 36 hours of the last dose of anastrozole or letrozole
Tumor tissue that is obtained for diagnosis or to assess response to initial AI therapy will be utilized for correlative studies A patient may be continued on anastrozole or letrozole beyond 4 weeks up to 18 weeks if in the opinion of the treating physician the patient will benefit from extended endocrine therapy In this context patients will have a core needle biopsy performed at 2-4 weeks after treatment to assess Ki67 response to AI therapy Patients with an appropriate response to treatment as determined by a decrease in Ki67 levels 10 will be continued on AI treatment Patients without an appropriate decrease in Ki67 levels will be recommended to have immediate surgery or a switch to neoadjuvant chemotherapy if desired by the patient and treating physician
Patients on extended AI neoadjuvant treatment having core biopsy at 2-4 weeks for Ki67 determination for clinical decision making will be approached and consented for additional research tissues to be taken at the same time as the biopsy for Ki67 determination Blood samples will be collected prior to starting treatment and within 3 days or on the day of surgery Additional blood samples will be obtained as clinically necessary
Clinical assessment will be performed prior to enrollment and within 3 days or on the day of surgery For patients who continue neoadjuvant endocrine therapy past 4 weeks clinical assessment will be performed at the time of clinical biopsy and every 4-6 weeks thereafter For clinical evidence of progression patients will be offered immediate surgery or switch to neoadjuvant chemotherapy at the discretion of the treating physician
Radiological assessment including mammogram ultrasound and breast MRI will be performed as per standard of care
Patients will be followed for 30 days on study after the last dose of anastrozole or letrozole prior to surgery For patients who receive extended neoadjuvant therapy with anastrozole or letrozole and for patients who receive other primary treatment after anastrozole or letrozole administration prior to surgery patients will be followed for 30 days on study after the last dose of anastrozole or letrozole Patients continuing to experience adverse events attributable to anastrozole or letrozole will be followed as needed until resolution or stabilization of the adverse events Patients who are either found to be ineligible or refuse to start treatment after consenting will not be followed and will be replaced Their information will not be collected After 30 days after the last dose of anastrozole or letrozole if there are no continuing adverse events attributable to treatment patients will be off study
A total of 90 patients will be enrolled with 15 patients in each cohort below
Cohort 1 Patients with BMI 250 kgm2 treating with anastrozole
Cohort 2 Patients with BMI 250-299 kgm2 treating with anastrozole
Cohort 3 Patients with BMI 30 kgm2 treating with anastrozole
Cohort 4 Patients with BMI 250 kgm2 treating with letrozole
Cohort 5 Patients with BMI 250-299 kgm2 treating with letrozole
Cohort 6 Patients with BMI 30 kgm2 treating with letrozole
Based on the patients calculated BMI patients in each BMI category normal overweight and obese will be enrolled in the different cohorts as described above The first 15 patients in each BMI category will be treated with anastrozole After completion of enrollment in cohorts 1 2 and 3 subsequent patients will be treated with letrozole in cohorts 4 5 and 6
Anastrozole 1 mg or Letrozole 25 mg oral daily will be administered and continued for a minimum of 14 days and a maximum of 28 days 2-4 weeks Surgery will be performed between weeks 2-3 of treatment unless there are compelling medical or personal reasons that prevent a patient from having surgery during this time In those cases patients may continue anastrozole or letrozole up to 4 weeks before surgery Surgery should be performed within 36 hours of the last dose of anastrozole or letrozole
Tumor tissue that is obtained for diagnosis or to assess response to initial AI therapy will be utilized for correlative studies A patient may be continued on anastrozole or letrozole beyond 4 weeks up to 18 weeks if in the opinion of the treating physician the patient will benefit from extended endocrine therapy In this context patients will have a core needle biopsy performed at 2-4 weeks after treatment to assess Ki67 response to AI therapy Patients with an appropriate response to treatment as determined by a decrease in Ki67 levels 10 will be continued on AI treatment Patients without an appropriate decrease in Ki67 levels will be recommended to have immediate surgery or a switch to neoadjuvant chemotherapy if desired by the patient and treating physician
Patients on extended AI neoadjuvant treatment having core biopsy at 2-4 weeks for Ki67 determination for clinical decision making will be approached and consented for additional research tissues to be taken at the same time as the biopsy for Ki67 determination Blood samples will be collected prior to starting treatment and within 3 days or on the day of surgery Additional blood samples will be obtained as clinically necessary
Clinical assessment will be performed prior to enrollment and within 3 days or on the day of surgery For patients who continue neoadjuvant endocrine therapy past 4 weeks clinical assessment will be performed at the time of clinical biopsy and every 4-6 weeks thereafter For clinical evidence of progression patients will be offered immediate surgery or switch to neoadjuvant chemotherapy at the discretion of the treating physician
Radiological assessment including mammogram ultrasound and breast MRI will be performed as per standard of care
Patients will be followed for 30 days on study after the last dose of anastrozole or letrozole prior to surgery For patients who receive extended neoadjuvant therapy with anastrozole or letrozole and for patients who receive other primary treatment after anastrozole or letrozole administration prior to surgery patients will be followed for 30 days on study after the last dose of anastrozole or letrozole Patients continuing to experience adverse events attributable to anastrozole or letrozole will be followed as needed until resolution or stabilization of the adverse events Patients who are either found to be ineligible or refuse to start treatment after consenting will not be followed and will be replaced Their information will not be collected After 30 days after the last dose of anastrozole or letrozole if there are no continuing adverse events attributable to treatment patients will be off study
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