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

NCT02953860 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-1001.cc
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Advanced Breast Cancer; ER+/Her2 Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant

  To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.

  24 Weeks

Secondary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)

  24 Weeks

• Percent Progression Free at 24 Weeks

  Up to 24 Weeks

Study Arms (1)

Fulvestrant with Enzalutamide

EXPERIMENTAL

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

Interventions

Fulvestrant with Enzalutamide DRUG

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.

Also known as: FASLODEX, MDV3100

Fulvestrant with Enzalutamide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ER+ Her2- breast cancer
• Metastatic
• Female, at least 18 years of age
• Candidate for fulvestrant therapy - patients who have started fulvestrant may enter this trial if within 3 months of starting fulvestrant
• Measurable or evaluable by RECIST 1.1
• ECOG PS 0-2
• Able to swallow study drug and comply with study requirements
• 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.
• 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.
• ANC \>1000/uL and 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (3)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; enzalutamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

limited size of trial not randomized heavily pretreated somewhat heterogeneous population

Results Point of Contact

• Title: Professor Anthony Elias
• Organization: University of Colorado

anthony.elias@cuanschutz.edu

720-848-0347

Study Officials

• Anthony D Elias, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: July 6, 2017
• Primary Completion: November 21, 2019
• Study Completion: April 10, 2020
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)