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

Plain-language summary

This study evaluates the drug Fulvestrant, used alone or together with Enzalutamide, before surgery in patients with estrogen receptor-positive, HER2-negative breast cancer. It includes patients over 18 with at least stage T2 disease who are postmenopausal (or receiving ovarian suppression) and have surgery planned. It is being conducted in Phase 2 and is currently active but not recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

University of Colorado, Denver

Intervention

Enzalutamide, Fulvestrant

Start date

9/21/2017

Estimated completion

2/1/2027

Countries

United States

Related genes

Locations

• Aurora, United States
• New York, United States
• Germantown, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.