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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 : December 19, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Enzalutamide Drug: Fulvestrant Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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)
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955394


Contacts
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Contact: Tiffany Colvin 720-848-0664 TIFFANY.COLVIN@UCDENVER.EDU

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    720-848-0664    tiffany.colvin@ucdenver.edu   
Principal Investigator: Anthony D Elias, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Monica Fornier, MD       fornierm@mskcc.org   
Principal Investigator: Monica Fornier, MD         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Gregory Vidal, MD       gvidal@westclinic.com   
Principal Investigator: Gregory Vidal, MD         
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
Investigators
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Principal Investigator: Anthony D Elias, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02955394     History of Changes
Other Study ID Numbers: 16-1042.cc
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
ER+/Her2 - breast cancer
Preoperative Fulvestrant
Enzalutamide

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs