Clinical Trials /

Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

NCT01560416

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

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

  • Breast Cancer

Interventions

DrugSynonymsArms
FulvestrantFaslodexFulvestrant
GanetespibSTA9090Fulvestrant+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

NameTypeDescriptionInterventions
FulvestrantActive ComparatorFulvestrant
  • Fulvestrant
Fulvestrant+GanetespibActive ComparatorFulvestrant and Ganetespib
  • Fulvestrant
  • Ganetespib
Cross-OverActive ComparatorFulvestrant and Ganetespib for participants originally assigned to arm A
  • Fulvestrant
  • Ganetespib

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