Clinical Trials /

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

NCT02953860

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
  • Official Title: Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16-1001.cc
  • NCT ID: NCT02953860

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Fulvestrant with EnzalutamideFASLODEX, MDV3100Fulvestrant with Enzalutamide

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Fulvestrant with EnzalutamideExperimental500mg 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.
  • Fulvestrant with Enzalutamide

Eligibility Criteria

Inclusion Criteria:

- ER+ Her2- breast cancer

- Metastatic

- 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

- 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 @4 weeks). (The patient will be asked if they would be willing to provide a third biopsy at time of progression)

- Patients may already have gotten the loading doses of fulvestrant and/or ovarian suppression

- If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression.

- 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

- 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.

Maximum Eligible Age:101 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical benefit rate of the combination of enzalutamide/ fulvestrant
Time Frame:24 Weeks
Safety Issue:
Description:Clinical benefit rate

Secondary Outcome Measures

Measure:Androgen receptor (AR) expression in breast tissue in the tumor biopsies of each patient
Time Frame:24 Weeks
Safety Issue:
Description: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
Measure:Progression-free survival (PFS)
Time Frame:24 Weeks
Safety Issue:
Description: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.
Measure:Overall response rate
Time Frame:24 Weeks
Safety Issue:
Description:
Measure:AR signaling in breast cancer tissue in the tumor biopsies
Time Frame:24 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Anthony Elias

Trial Keywords

  • Advanced Breast Cancer
  • ER+/Her2 Advanced Breast Cancer

Last Updated

December 20, 2016