Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
NCT ID: NCT02955394
Last Updated: 2025-07-09
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
61 participants
INTERVENTIONAL
2017-09-21
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fulvestrant Without Enzalutamide
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant
500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Fulvestrant With Enzalutamide
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.
Enzalutamide
160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant
500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Interventions
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Enzalutamide
160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrant
500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
101 Years
FEMALE
No
Sponsors
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United States Department of Defense
FED
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Anthony D Elias, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
West Cancer Center
Germantown, Tennessee, United States
Countries
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References
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Elebro K, Borgquist S, Simonsson M, Markkula A, Jirstrom K, Ingvar C, Rose C, Jernstrom H. Combined Androgen and Estrogen Receptor Status in Breast Cancer: Treatment Prediction and Prognosis in a Population-Based Prospective Cohort. Clin Cancer Res. 2015 Aug 15;21(16):3640-50. doi: 10.1158/1078-0432.CCR-14-2564. Epub 2015 Apr 22.
Hu R, Dawood S, Holmes MD, Collins LC, Schnitt SJ, Cole K, Marotti JD, Hankinson SE, Colditz GA, Tamimi RM. Androgen receptor expression and breast cancer survival in postmenopausal women. Clin Cancer Res. 2011 Apr 1;17(7):1867-74. doi: 10.1158/1078-0432.CCR-10-2021. Epub 2011 Feb 15.
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D'Amato NC, Gordon MA, Babbs B, Spoelstra NS, Carson Butterfield KT, Torkko KC, Phan VT, Barton VN, Rogers TJ, Sartorius CA, Elias A, Gertz J, Jacobsen BM, Richer JK. Cooperative Dynamics of AR and ER Activity in Breast Cancer. Mol Cancer Res. 2016 Nov;14(11):1054-1067. doi: 10.1158/1541-7786.MCR-16-0167. Epub 2016 Aug 26.
Takagi K, Miki Y, Nagasaki S, Hirakawa H, Onodera Y, Akahira J, Ishida T, Watanabe M, Kimijima I, Hayashi S, Sasano H, Suzuki T. Increased intratumoral androgens in human breast carcinoma following aromatase inhibitor exemestane treatment. Endocr Relat Cancer. 2010 Apr 21;17(2):415-30. doi: 10.1677/ERC-09-0257. Print 2010 Jun.
Elias A, Richer JK, LoRusso P, Peterson AC, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase 1 open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. ASCO 2012, TPS668
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.
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Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G; IMPACT Trialists. Short-term changes in Ki-67 during neoadjuvant treatment of primary breast cancer with anastrozole or tamoxifen alone or combined correlate with recurrence-free survival. Clin Cancer Res. 2005 Jan 15;11(2 Pt 2):951s-8s.
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Ellis MJ, Llombart-Cussac A, Feltl D, Dewar JA, Jasiowka M, Hewson N, Rukazenkov Y, Robertson JF. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. doi: 10.1200/JCO.2015.61.5831. Epub 2015 Sep 14.
Robertson JF, Lindemann JP, Llombart-Cussac A, Rolski J, Feltl D, Dewar J, Emerson L, Dean A, Ellis MJ. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized 'FIRST' study. Breast Cancer Res Treat. 2012 Nov;136(2):503-11. doi: 10.1007/s10549-012-2192-4. Epub 2012 Oct 13.
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Elias AD, Staley AW, Fornier M, Vidal GA, Alami V, Sams S, Spoelstra NS, Goodspeed A, Kabos P, Diamond JR, Shagisultanova E, Gallagher RI, Wulfkuhle JD, Petricoin EF, Zolman KL, McSpadden T, Jordan KR, Slansky JE, Borges VF, Gao D, Richer JK. Clinical and immune responses to neoadjuvant fulvestrant with or without enzalutamide in ER+/Her2- breast cancer. NPJ Breast Cancer. 2024 Oct 6;10(1):88. doi: 10.1038/s41523-024-00697-5.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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16-1042.cc
Identifier Type: -
Identifier Source: org_study_id
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