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Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02953860
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 3, 2016
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE July 6, 2017
Actual Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
Clinical benefit rate of the combination of enzalutamide/ fulvestrant [ Time Frame: 24 Weeks ]
To determine the clinical benefit rate (complete and partial response plus stable disease for 24 weeks) of the combination of enzalutamide/fulvestrant.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Clinical benefit rate of the combination of enzalutamide/ fulvestrant [ Time Frame: 24 Weeks ]
Clinical benefit rate
Change History Complete list of historical versions of study NCT02953860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • Incidence of Treatment-Emergent Adverse Events (Safety Profile) [ Time Frame: 24 Weeks ]
    The safety of the combination of enzalutamide with fulvestrant will be assessed according to CTCAE 4.03.
  • Overall Response Rate [ Time Frame: 24 Weeks ]
    Tumor response will be assessed using RECIST 1.1
  • Progression-Free Survival (PFS) [ Time Frame: Up to 24 Weeks ]
    PFS is defined as the time from the first day of enzalutamide treatment (Study Day 1) until documented disease progression or death on study, whichever occurs first. PFS will be measured at 12 and 24 weeks.
  • AR signaling in breast cancer tissue in the tumor biopsies [ Time Frame: 24 Weeks ]
    To obtain serial biopsies of breast cancer pretreatment, during treatment and at time of tumor progression in order to determine the extent of AR expression and signaling in breast tissue, to evaluate the effect of enzalutamide on the tumor, and to evaluate the relationship of these effects on clinical outcomes.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • Androgen receptor (AR) expression in breast tissue in the tumor biopsies of each patient [ Time Frame: 24 Weeks ]
    Patient biopsies will be obtained pretreatment, during treatment, and at the time of tumor progression to determine the AR expression and signaling in the breast tissue. The degree of AR expression in the nucleus will be reported by immunohistochemistry (IHC) strength of staining (0-3+) and % nuclei stained and the relationship between tumor response and degree of AR expression and/or AR signaling will be examined
  • Progression-Free Survival (PFS) [ Time Frame: 24 Weeks ]
    PFS is defined as the time from the first day of enzalutamide treatment (Study Day 1) until documented disease progression or death on study, whichever occurs first.
  • Overall Response Rate [ Time Frame: 24 Weeks ]
  • AR signaling in breast cancer tissue in the tumor biopsies [ Time Frame: 24 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
Official Title  ICMJE Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
Brief Summary A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and Her2 normal.
Detailed Description This is a single arm, non-randomized, open-label phase 2 study designed to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR-positive and Her2 normal. In this study 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be, in conjunction with Fulvestrant, PO daily.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Fulvestrant with Enzalutamide
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
Other Names:
  • FASLODEX
  • MDV3100
Study Arms  ICMJE Experimental: Fulvestrant with Enzalutamide
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Intervention: Drug: Fulvestrant with Enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 9, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
24
Estimated Study Completion Date  ICMJE November 2021
Actual Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ER+ Her2- breast cancer
  2. Metastatic
  3. Female, at least 18 years of age
  4. Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant
  5. Measurable or evaluable by RECIST 1.1
  6. ECOG PS 0-2
  7. Able to swallow study drug and comply with study requirements
  8. Tumor available for fresh biopsy (two biopsies - pretreatment as regards enzalutamide, and during treatment at 4 weeks). The patient will be also be asked if they would be willing to provide a third biopsy at time of progression.
  9. If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression. Patients may have already gotten the loading dose of ovarian suppression. Pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening.
  10. ANC >1000/uL and platelets >75,000/uL at screening visit
  11. Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)
  12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases
  13. Creatinine < 1.5 times ULN
  14. INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy
  15. Willing to donate blood for research at 4 time points
  16. Written informed consent obtained prior to biopsies and blood samples
  17. Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued.

Exclusion Criteria:

  1. Current or previously treated brain or leptomeningeal metastases
  2. History of seizures
  3. Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464)
  4. Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953860
Other Study ID Numbers  ICMJE 16-1001.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Anthony D Elias, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2019

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