Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 6, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Drug: Ganetespib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 71
Study Start Date: May 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fulvestrant
Fulvestrant
Drug: Fulvestrant
injection on day 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle
Active Comparator: Fulvestrant+Ganetespib
Fulvestrant and Ganetespib
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: Cross-Over
Fulvestrant and Ganetespib for participants originally assigned to arm A
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560416

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, M.D.    617-632-2335    nlin@partners.org   
Principal Investigator: Nancy Lin, M.D.         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, M.D.    617-632-2335    nlin@partners.org   
Principal Investigator: Nancy Lin, M.D.         
DFCI at Faulkner Hospital Terminated
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nadine Tung, MD    617-667-1962      
Principal Investigator: Nadine Tung, MD         
United States, New Hampshire
New Hampshire Oncology and Hematology, P.A. Recruiting
Concord, New Hampshire, United States, 03301
Contact: Douglas Weckstein, MD    603-622-6484      
Principal Investigator: Douglas Weckstein, MD         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carey Anders, MD    919-843-7719      
Principal Investigator: Carey Anders, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Nancy U Lin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Nancy Lin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01560416     History of Changes
Other Study ID Numbers: 11-477
Study First Received: February 21, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic
HR positive
ER positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on July 26, 2014