Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2019 |
| Start Date: | May 2012 |
| End Date: | June 2016 |
Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer
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.
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.
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.
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.
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
We found this trial at
5
sites
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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