Description:
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.
Title
- Brief Title: Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
- Official Title: Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
11-477
- NCT ID:
NCT01560416
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Fulvestrant | Faslodex | Fulvestrant |
| Ganetespib | STA9090 | Fulvestrant+Ganetespib |
Purpose
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.
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 drug(s), blood
tests, clinical exams and scans/imaging tests.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Fulvestrant | Active Comparator | Fulvestrant | |
| Fulvestrant+Ganetespib | Active Comparator | Fulvestrant and Ganetespib | |
| Cross-Over | Active Comparator | Fulvestrant and Ganetespib for participants originally assigned to arm A | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Effect of Adding Ganetespib to Fulvestrant |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Evaluate the effect of the addition of ganetespib to fulvestrant on progression-free survival (PFS), compared to fulvestrant alone |
Secondary Outcome Measures
| Measure: | Number of participants with adverse events after treatment with Ganetespib Plus Fulvestrant |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To describe the grade and frequency of adverse events according to CTCAE v 4.0 in patients treated with ganetespib in combination with fulvestrant and in patients treated with fulvestrant alone |
| Measure: | Objective Response Rate Between Arms by RECIST |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To describe and compare the objective response rate by RECIST 1.1 between arms, limited to patients with measurable disease at baseline |
| Measure: | Comparison of Clinical Benefit Rate Between Arms |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To describe and compare the clinical benefit rate, defined as complete response (CR)+partial response (PR)+stable disease >/= 6 months between arms |
| Measure: | Comparison of Overall Survival Between Arms |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | To describe and compare overall survival (OS) between arms |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Dana-Farber Cancer Institute |
Trial Keywords
- Metastatic
- HR positive
- ER positive
Last Updated
October 2, 2017
