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Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

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ClinicalTrials.gov Identifier: NCT02955394
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : January 27, 2020
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 4, 2016
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE September 21, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
Document the number of patients in both treatment arms separately who have a PEPI score equal to 0 at post treatment [ Time Frame: 16 Weeks ]
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
Document the number of patients in both treatment arms separately who have a PEPI score equal to 0 at 16 weeks post treatment [ Time Frame: 16 Weeks ]
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • Progression-free survival (PFS) [ Time Frame: 16 Weeks ]
    To determine the percentage of progression-free survival (PFS) (complete and partial response plus stable disease) for the single drug arm and combination of enzalutamide/fulvestrant arm separately.
  • Correlate PEPI score and Progression-free survival, Clinical Benefit Rate, and Overall Response Rate [ Time Frame: 16 Weeks ]
    To assess the association between PEPI score and the clinical, outcomes such as PFS, ORR, clinical benefit for all subjects.
  • Androgen Receptor (AR) expression [ Time Frame: 16 Weeks ]
    Nuclear AR expression and AR pathway expression correlation with clinical outcomes. AR expression is associated with resistance to anti-estrogen therapy. Its blockade may enhance response.
  • Clinical Benefit Rate [ Time Frame: 16 weeks ]
    To determine the percentage of clinical benefit rate (complete and partial response plus stable disease) for the single drug arm and combination of enzalutamide/fulvestrant arm separately.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Progression-free survival [ Time Frame: 16 Weeks ]
    PFS
  • Correlate PEPI score and PFS [ Time Frame: 16 Weeks ]
  • Androgen Receptor (AR) expression [ Time Frame: 16 Weeks ]
    Nuclear AR expression and AR pathway expression correlation with clinical outcomes.
  • Clinical Benefit Rate [ Time Frame: 16 weeks ]
    CBR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Official Title  ICMJE Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Brief Summary This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.
Detailed Description This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment. After consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. At ~4 weeks, a biopsy will be done and therapy will be continued. Hormone therapy will continue for ~4 months at which point the patients will undergo surgical resection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
    Other Name: MDV3100
  • Drug: Fulvestrant
    500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
    Other Name: FASLODEX
Study Arms  ICMJE
  • Placebo Comparator: Fulvestrant Without Enzalutamide
    500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
    Intervention: Drug: Fulvestrant
  • Experimental: Fulvestrant With Enzalutamide
    500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.
    Interventions:
    • Drug: Enzalutamide
    • Drug: Fulvestrant
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
61
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ER+ Her2- breast cancer
  • Stage at least T2 or greater
  • Planned to get local surgery
  • Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression.
  • At least 18 years of age
  • Not on anticoagulants
  • PS 0-2
  • Able to swallow study drug and comply with study requirements
  • ANC >1000/uL, platelets >75,000/uL at screening visit
  • Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases
  • Creatinine < 1.5 times ULN
  • INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy
  • Willing to donate blood for research at 4 time points
  • Willing to undergo core biopsies for research at study entry and at ~4 weeks.
  • Willing to donate tissue to research from the surgical specimen
  • Written informed consent obtained prior to biopsies and blood samples

Exclusion Criteria:

  • Current or previously treated brain or leptomeningeal metastases
  • History of seizures
  • Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).
  • 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 101 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tiffany Colvin 720-848-0664 TIFFANY.COLVIN@UCDENVER.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955394
Other Study ID Numbers  ICMJE 16-1042.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 January 2020

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