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

NCT02955394 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-1042.cc
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

ER+/Her2 - breast cancer; Preoperative Fulvestrant; Enzalutamide

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 Weeks

Secondary Outcomes (3)

• Disease-free Survival

  15 months

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

  4 years

• Androgen Receptor (AR) Expression

  16 Weeks

Study Arms (2)

Fulvestrant Without Enzalutamide

PLACEBO COMPARATOR

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

Fulvestrant With Enzalutamide

EXPERIMENTAL

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; Drug: Fulvestrant

Interventions

Enzalutamide DRUG

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

Also known as: MDV3100

Fulvestrant With Enzalutamide

Fulvestrant DRUG

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

Also known as: FASLODEX

Fulvestrant With Enzalutamide; Fulvestrant Without Enzalutamide

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Related Publications (19)

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  PMID: 39368973 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

enzalutamide; Fulvestrant

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

Results Point of Contact

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

anthony.elias@cuasnchutz.edi

720-848-0300

Study Officials

• Anthony D Elias, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 4, 2016
• Study Start: September 21, 2017
• Primary Completion: February 17, 2023
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 9, 2025
• Results First Posted: June 15, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)