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NCT Number: NCT02955394

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–101 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enzalutamide

Drug

160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.

Other names: MDV3100

Fulvestrant

Drug

500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)

Other names: FASLODEX

Primary outcomes

  1. Number of Patients With a PEPI Score Equal to Zero at Post Treatment

    Time frame: 16 Weeks

    The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence.

    PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and >= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better.

Secondary outcomes

  1. Disease-free Survival

    Time frame: 15 months

    Disease-free survival is defined as the time in months from the start of fulvestrant until documented disease progression or death. Complete and partial response for the single drug arm and combination of enzalutamide/fulvestrant arm separately.

  2. Correlation Between PEPI Score and Disease-free Survival, Clinical Benefit Rate, and Overall Response Rate

    Time frame: 4 years

    To assess the association between PEPI score and the clinical, outcomes such as DFS, ORR, clinical benefit for all subjects.

  3. Androgen Receptor (AR) Expression

    Time frame: 16 Weeks

    The strength of AR signaling was measured by the percentage of downstream AR-regulated genes that were expressed.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Nov 4, 2016
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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