Breast Cancer Clinical Trial

Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

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.

View Full Description

Full 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 drug(s), blood tests, clinical exams and scans/imaging tests.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced
Estrogen and/or progesterone receptor positive breast cancer
HER2 negative
Measurable disease is required (effective 4/30/14: all non-measurable [evaluable] disease slots have been filled)
Endocrine resistant breast cancer
May have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer
May have initiated bisphosphonate therapy prior to start of protocol therapy
Must be at least 2 weeks from prior chemotherapy or radiotherapy
ECOG performance status of 0 or 1
Availability of tissue block from initial breast cancer diagnosis and/or metastatic recurrence
For subjects with biopsy-accessible disease, must be willing to undergo a required on-treatment research biopsy
Adequate IV access

Exclusion Criteria:

Pregnant or breastfeeding
Prior treatment with HSP90 inhibitor
Prior treatment with fulvestrant
Concurrent treatment with commercial agents or other agents with the intent to treat the participant's malignancy
Untreated or progressive brain metastases
Pending visceral crisis, in the opinion of the treating investigator
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fulvestrant or ganetespib
Uncontrolled intercurrent illness
Other malignancies within 3 years

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT01560416

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

DFCI at Faulkner Hospital
Boston Massachusetts, 02130, United States
Brigham and Women's Hospital
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
New Hampshire Oncology and Hematology, P.A.
Concord New Hampshire, 03301, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT01560416

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider