Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT02953860 |
Recruitment Status :
Completed
First Posted : November 3, 2016
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Fulvestrant with Enzalutamide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer |
Actual Study Start Date : | July 6, 2017 |
Actual Primary Completion Date : | November 21, 2019 |
Actual Study Completion Date : | April 10, 2020 |

Arm | Intervention/treatment |
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Experimental: Fulvestrant with Enzalutamide
500mg 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.
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Drug: Fulvestrant with Enzalutamide
500mg 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 PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
Other Names:
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- Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant [ Time Frame: 24 Weeks ]To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.
- Number of Participants With Treatment-Emergent Adverse Events (Safety Profile) [ Time Frame: 24 Weeks ]The safety of the combination of enzalutamide with fulvestrant will be assessed according to CTCAE 4.03.
- Percent Progression Free at 24 Weeks [ Time Frame: Up to 24 Weeks ]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. Percent (%) progression free at 24 weeks is the number of patients without disease progression after 24 weeks follow-up.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953860
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
Lone Tree Medical Center | |
Lone Tree, Colorado, United States, 80124 | |
United States, Tennessee | |
West Cancer Center | |
Germantown, Tennessee, United States, 38138 |
Principal Investigator: | Anthony D Elias, MD | University of Colorado, Denver |
Documents provided by University of Colorado, Denver:
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02953860 |
Other Study ID Numbers: |
16-1001.cc |
First Posted: | November 3, 2016 Key Record Dates |
Results First Posted: | May 14, 2021 |
Last Update Posted: | May 14, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Advanced Breast Cancer ER+/Her2 Advanced Breast Cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents, Hormonal |
Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |