Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953860
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall Response Rate [ Time Frame: 24 Weeks ]
    Tumor response will be assessed using RECIST 1.1

  3. 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.

  4. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02953860


Contacts
Layout table for location contacts
Contact: Tiffany Colvin 720-848-0664 TIFFANY.COLVIN@UCDENVER.EDU

Locations
Layout table for location information
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    303-848-0664    TIFFANY.COLVIN@UCDENVER.EDU   
Principal Investigator: Anthony D Elias, MD         
Lone Tree Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Lisa Lopez       lisa.lopez@ucdenver.edu   
Principal Investigator: Regina Brown, MD         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Julie Ryder    901-683-0055    jryder@westclinic.com   
Principal Investigator: Gregory Vidal, MD         
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Anthony D Elias, MD University of Colorado, Denver

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02953860     History of Changes
Other Study ID Numbers: 16-1001.cc
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Advanced Breast Cancer
ER+/Her2 Advanced Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
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