Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01560416
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2012-02-21
Brief Title:
Fulvestrant With or Without Ganetespib in HR Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
Ganetespib is a drug that may stop cancer cells from growing This drug has been used in other research studies and laboratory experiments It has also been studied in phase I trials where the appropriate dosing has been determined Ganetespib is considered an HSP90 inhibitor By blocking HSP90 ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment
Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors In doing so it can block the effect of estrogen on cancer cells In addition fulvestrant causes a decrease in the number of estrogen receptors Fulvestrant is a drug that is approved by the FDA for treatment of metastatic hormone receptor positive breast cancer based upon the results of phase III clinical trials
In the laboratory adding ganetespib to fulvestrant appears to improve its effectiveness It is not known whether this is true in humans In this research study we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive metastatic breast cancer
Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors In doing so it can block the effect of estrogen on cancer cells In addition fulvestrant causes a decrease in the number of estrogen receptors Fulvestrant is a drug that is approved by the FDA for treatment of metastatic hormone receptor positive breast cancer based upon the results of phase III clinical trials
In the laboratory adding ganetespib to fulvestrant appears to improve its effectiveness It is not known whether this is true in humans In this research study we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive metastatic breast cancer
Detailed Description:
Because no one knows which of the study options is best you will be randomized into one of the study groups Arm A Fulvestrant or Arm B Fulvestrant plus Ganetespib You will have a one-third chance of being placed in Arm A and a two-thirds chance of being placed in Arm B
If you are initially placed in Arm A but your disease progresses you will have the option of receiving the combination of fulvestrant plus ganetespib as part of Arm C
You will undergo the following procedures during the research study study drugs blood tests clinical exams and scansimaging tests
If you are initially placed in Arm A but your disease progresses you will have the option of receiving the combination of fulvestrant plus ganetespib as part of Arm C
You will undergo the following procedures during the research study study drugs blood tests clinical exams and scansimaging tests
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