Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Ganetespib
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized 2:1 B Fulvestrant+Ganetespib:A Fulvestrant
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; HR positive; ER positive

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.
    

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