Phase 2
N=32
Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02953860 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
May 2021
Primary outcome: Primary: Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fulvestrant with Enzalutamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant |
7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (Safety Profile) |
17; 16; 9; 10; 11; 7 | — |
| SECONDARY Percent Progression Free at 24 Weeks |
7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Written informed consent obtained prior to biopsies and blood samples
- Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued.
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.
Data sourced from ClinicalTrials.gov (NCT02953860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.