Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405938
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2006-11-28
Brief Title:
Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Trial of Open-Label Bevacizumab Administered With Anastrozole or Fulvestrant as First-Line Therapy in Postmenopausal Hormone Receptor- Positive Metastatic Breast Cancer With Trastuzumab in HER2-Positive Patients
Status:
COMPLETED
Status Verified Date:
2021-11
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:
This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women It is hoped that these combinations will keep the cancer from growing and spreading further
Detailed Description:
Regimen A Bevacizumabanastrozole with trastuzumab in HER2 patients Bevacizumab 10mgkg IV every 2 weeks patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mgkg every 3 weeks instead of 10 mgkg every 2 weeks see Trastuzumab section below and anastrozole 1 mg orally daily Treatment will be given in 4-week cycles Response assessments will be performed after 2 cycles Patients who respond to treatment or have stable disease will continue to be evaluated every 2 cycles After 6 months response assessment will occur every 3 months A patient may remain on study if radiation is deemed necessary and appropriate provided that there are other sites of measurable disease outside the field of radiation that may be followed Treatment occurs until disease progression Patients will be selected for this treatment arm per the following guidelines 12 months from adjuvant endocrine therapy OR 12 months from adjuvant aromatase inhibitors OR Endocrine therapy naive OR Prior tamoxifen exposure or tamoxifen intolerance
Regimen B Bevacizumabfulvestrant with trastuzumab in HER2 patients Bevacizumab 10mgkg IV every 2 weeks patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mgkg every 3 weeks instead of 10 mgkg every 2 weeks see Trastuzumab section below fulvestrant 500 mg intramuscular on Day 1 of Cycle 1 followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1 On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter patients in this treatment arm will receive 250 mg intramuscularly of fulvestrant Treatment will be given in 4-week cycles Response assessments will be performed after 2 cycles Patients who respond to treatment or have stable disease will continue to be evaluated every 2 cycles After 6 months response assessment will occur every 3 months A patient may remain on study if radiation is deemed necessary and appropriate provided that there are other sites of measurable disease outside the field of radiation that may be followed Treatment occurs until disease progression Patients will be selected for this treatment arm per the following guidelines 12 months from adjuvant aromatase inhibitor therapy OR Intolerant of aromatase inhibitors OR Disease progression on adjuvant aromatase inhibitors OR Physician discretion
Trastuzumab Patients in Treatment Arm A or Treatment Arm B who have FISH HER2 or IHC3 breast cancer will also receive treatment with trastuzumab in addition to their treatment with the combination of bevacizumab with either anastrozole or fulvestrant Trastuzumab will be administered ONLY to patients with HER2 breast cancer FISH-positive or IHC3 An 8 mgkg loading dose of IV trastuzumab will be administered on Day 1 followed by doses of 6 mgkg IV trastuzumab once every 3 weeks These patients will have the option of receiving their bevacizumab doses at 15 mgkg every 3 weeks rather than 10 mgkg every 2 weeks if they prefer to keep their bevacizumab dosing schedule consistent with their trastuzumab dosing schedule so that the number of visits they must make to the study site is minimized The dosing schedules for anastrozole for HER2 patients in Treatment Arm A and fulvestrant for HER2 patients in Treatment Arm B will not change
Regimen B Bevacizumabfulvestrant with trastuzumab in HER2 patients Bevacizumab 10mgkg IV every 2 weeks patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mgkg every 3 weeks instead of 10 mgkg every 2 weeks see Trastuzumab section below fulvestrant 500 mg intramuscular on Day 1 of Cycle 1 followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1 On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter patients in this treatment arm will receive 250 mg intramuscularly of fulvestrant Treatment will be given in 4-week cycles Response assessments will be performed after 2 cycles Patients who respond to treatment or have stable disease will continue to be evaluated every 2 cycles After 6 months response assessment will occur every 3 months A patient may remain on study if radiation is deemed necessary and appropriate provided that there are other sites of measurable disease outside the field of radiation that may be followed Treatment occurs until disease progression Patients will be selected for this treatment arm per the following guidelines 12 months from adjuvant aromatase inhibitor therapy OR Intolerant of aromatase inhibitors OR Disease progression on adjuvant aromatase inhibitors OR Physician discretion
Trastuzumab Patients in Treatment Arm A or Treatment Arm B who have FISH HER2 or IHC3 breast cancer will also receive treatment with trastuzumab in addition to their treatment with the combination of bevacizumab with either anastrozole or fulvestrant Trastuzumab will be administered ONLY to patients with HER2 breast cancer FISH-positive or IHC3 An 8 mgkg loading dose of IV trastuzumab will be administered on Day 1 followed by doses of 6 mgkg IV trastuzumab once every 3 weeks These patients will have the option of receiving their bevacizumab doses at 15 mgkg every 3 weeks rather than 10 mgkg every 2 weeks if they prefer to keep their bevacizumab dosing schedule consistent with their trastuzumab dosing schedule so that the number of visits they must make to the study site is minimized The dosing schedules for anastrozole for HER2 patients in Treatment Arm A and fulvestrant for HER2 patients in Treatment Arm B will not change
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