Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01560416
First received: February 21, 2012
Last updated: September 16, 2014
Last verified: September 2014

February 21, 2012
September 16, 2014
May 2012
February 2015   (final data collection date for primary outcome measure)
Effect of Adding Ganetespib to Fulvestrant [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluate the effect of the addition of ganetespib to fulvestrant on progression-free survival (PFS), compared to fulvestrant alone
Same as current
Complete list of historical versions of study NCT01560416 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events after treatment with Ganetespib Plus Fulvestrant [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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
  • Objective Response Rate Between Arms by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe and compare the objective response rate by RECIST 1.1 between arms, limited to patients with measurable disease at baseline
  • Comparison of Clinical Benefit Rate Between Arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe and compare the clinical benefit rate, defined as complete response (CR)+partial response (PR)+stable disease >/= 6 months between arms
  • Comparison of Overall Survival Between Arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe and compare overall survival (OS) between arms
Same as current
Not Provided
Not Provided
 
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Fulvestrant
    injection on day 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle
  • Drug: Ganetespib
    Intravenous, on days 1, 8 and 15 eof each cycle
  • Active Comparator: Fulvestrant
    Fulvestrant
    Intervention: Drug: Fulvestrant
  • Active Comparator: Fulvestrant+Ganetespib
    Fulvestrant and Ganetespib
    Interventions:
    • Drug: Fulvestrant
    • Drug: Ganetespib
  • Active Comparator: Cross-Over
    Fulvestrant and Ganetespib for participants originally assigned to arm A
    Interventions:
    • Drug: Fulvestrant
    • Drug: Ganetespib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
71
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01560416
11-477
Yes
Nancy Lin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Nancy U Lin, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP