Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200174
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2005-09-09
Brief Title:
Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease A Pilot Chemoprevention Trial
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
The purpose of this research study is to learn about the effects of two drugs when they are given together The names of the drugs are raloxifene and exemestane
Raloxifene is a drug that is related to estrogen In the liver and bone it acts like estrogen In the breast and uterus it acts like an anti-estrogen It has been used in postmenopausal women to prevent a disease called osteoporosis This is a disease that decreases bone strength over many years and may finally lead to bone fractures In a group of women who were taking the drug it also seemed to decrease the chances of breast cancer and possibly endometrial cancer cancer of the uterus Therefore we want to study it further to see if it prevents breast cancer We also want to find out if it may be even better in preventing breast cancer if it is given with another drug
The other drug in this trial is exemestane Exemestane is a type of drug that works to decrease estrogen levels in postmenopausal women This type of drug is used in women for the treatment of breast cancer Before we can decide if the two drugs combined are better for preventing breast cancer we must first test these drugs together to make sure that they are safe This safety testing is the purpose of this trial
Raloxifene is a drug that is related to estrogen In the liver and bone it acts like estrogen In the breast and uterus it acts like an anti-estrogen It has been used in postmenopausal women to prevent a disease called osteoporosis This is a disease that decreases bone strength over many years and may finally lead to bone fractures In a group of women who were taking the drug it also seemed to decrease the chances of breast cancer and possibly endometrial cancer cancer of the uterus Therefore we want to study it further to see if it prevents breast cancer We also want to find out if it may be even better in preventing breast cancer if it is given with another drug
The other drug in this trial is exemestane Exemestane is a type of drug that works to decrease estrogen levels in postmenopausal women This type of drug is used in women for the treatment of breast cancer Before we can decide if the two drugs combined are better for preventing breast cancer we must first test these drugs together to make sure that they are safe This safety testing is the purpose of this trial
Detailed Description:
The objectives of this project are to investigate the safety and toxicity of the combination of raloxifene a selective estrogen receptor modulator SERM with exemestane a new steroidal aromatase inhibitor in postmenopausal women with a history of breast cancer who have no clinical evidence of disease The study cohort will consist of postmenopausal women with a history of AJCC Stage 0 I II or III breast cancer after completion of all planned adjuvant therapy The study cohort is limited to patients who have not already received anti-estrogen therapy as part of post-operative adjuvant treatment Patients with a history of invasive ER- andor PR-positive breast cancer are eligible only if they have not received an anti-estrogen as part of adjuvant therapy and they are at least 2 years from the time of their primary surgery
Tamoxifen has been shown to reduce the incidence of contralateral breast cancer regardless of the estrogen expression of the primary tumor and may therefore be offered as a chemopreventive agent to patients who have not received an anti-estrogen in the adjuvant setting This population of patients is also a reasonable cohort in which to test other chemoprevention regimens Our hypothesis is that the combination of raloxifene and exemestane may offer an alternative treatment for chemoprevention that may prove to be more effective than an anti-estrogen alone
Endpoints of the study are to determine whether the combination of raloxifene and exemestane is safe and tolerable with respect to
1 markers of bone turnover and bone mineral density
2 the serum lipoprotein profile
3 quality of life in particular symptoms of estrogen deficiency
4 pharmacokinetics and pharmacodynamics of both drugs
We will also determine the feasibility of using mammography and breast MRI imaging to assess the effects of the combination on radiographic breast density
As part of a correlative laboratory study of breast biopsy material women may undergo an optional biopsy of their unaffected breast Breast biopsy material will be evaluated both pre- and 3 months post-treatment to determine whether the combination will have an impact on breast tissue aromatase activity and breast tissue estrogen levels and potential surrogate endpoint biological markers
Tamoxifen has been shown to reduce the incidence of contralateral breast cancer regardless of the estrogen expression of the primary tumor and may therefore be offered as a chemopreventive agent to patients who have not received an anti-estrogen in the adjuvant setting This population of patients is also a reasonable cohort in which to test other chemoprevention regimens Our hypothesis is that the combination of raloxifene and exemestane may offer an alternative treatment for chemoprevention that may prove to be more effective than an anti-estrogen alone
Endpoints of the study are to determine whether the combination of raloxifene and exemestane is safe and tolerable with respect to
1 markers of bone turnover and bone mineral density
2 the serum lipoprotein profile
3 quality of life in particular symptoms of estrogen deficiency
4 pharmacokinetics and pharmacodynamics of both drugs
We will also determine the feasibility of using mammography and breast MRI imaging to assess the effects of the combination on radiographic breast density
As part of a correlative laboratory study of breast biopsy material women may undergo an optional biopsy of their unaffected breast Breast biopsy material will be evaluated both pre- and 3 months post-treatment to determine whether the combination will have an impact on breast tissue aromatase activity and breast tissue estrogen levels and potential surrogate endpoint biological markers
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