Breast CancerPhase 2NCT02750358
Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer
A Phase 2 study testing Enzalutamide and assessment in people with Breast Cancer and Early Stage, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Early Stage, Triple Negative Breast Cancer
- What is being tested?
- Enzalutamide and assessment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 May 2016to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1, PR <1 and HER2 0 or 1+ or FISH not amplified if IHC 2+.
- AR testing may be performed while patient is undergoing other adjuvant therapy (i.e., surgery, chemotherapy, radiation).
- Willing and able to provide informed consent. Woman at least 18 years of age.
- Patient is a candidate for treatment of their early stage breast cancer.
- The study population for Step 2 will meet the eligibility criteria:
- Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1%, PR <1% and HER2 0 or 1+ or FISH not amplified if IHC 2+.
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- AR(+), defined as ≥1% nuclear staining by IHC testing. The assessment of AR expression may have been performed any time in the past and is not limited to participation in Step 1.
- Any neoadjuvant or adjuvant chemotherapy regimen is permitted. Prior chemotherapy for the treatment of this breast cancer is not required.
- At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution of any toxicity to Grade 1 or less, excluding alopecia.
- Patients are eligible to participate within 6 months of completion of therapy for their breast cancer. This includes prior radiation therapy if needed.
- ECOG performance status of 0 or 1.
- Willing and able to provide informed consent.
- Woman at least 18 years of age.
- Able to swallow study drug and comply with study requirements.
- Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
- Is not breastfeeding at screening and will not breastfeed throughout the study period and for at least 3 months after final drug administration.
Who cannot join
- Each patient eligible to participate in this study must NOT meet any of the following exclusion criteria.
- Any severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirements.
- Evidence of metastatic/Stage 4 breast cancer
- History of another invasive cancer within 5 years with the exceptions of nonmelanoma skin cancers and AJCC Stage 0 or 1 cancers that have a remote probability of recurrence in the opinion of the investigator
- Absolute neutrophil count < 1500/μL, platelet count < 75,000/μL, or hemoglobin < 9 g/dL (5.6 mmol/L).
- Total bilirubin > 1.5 times upper limit of normal (ULN) unless an alternate nonmalignant etiology exists (eg, Gilbert's disease). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times ULN.
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- Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute calculated using the Cockcroft-Gault equation.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months before day 1
- An active gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer disease, uncontrolled celiac)
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Kings County Hopsital Center
Brooklyn, New York, 11203
Coney Island Hospital
Brooklyn, New York, 11235
Woodhull Hospital
Brooklyn, New York
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Queens Hospital Center
Jamaica, New York, 11432
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR(+) Triple Negative Breast Cancer
This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).
- Conditions
- Breast Cancer, Early Stage, Triple Negative Breast Cancer
- Being tested
- Enzalutamide, assessment
- Keywords
- Enzalutamide, 15-307
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
assessmentBehavioural
Also called Functional Assessment of Cancer Therapy-Breast (FACT-B) scale
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | 160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window). Receives: Drug: Enzalutamide; Behavioral: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment discontinuation rate of enzalutamide in the adherent population
feasibility
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start19 May 2016
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medivation, Inc., Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Tiffany Traina, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750358
- Sponsor's protocol ID
- 15-307
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR(+) Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02750358
- Acronym / sponsor ID
- 15-307
- Conditions
- Breast Cancer, Early Stage, Triple Negative Breast Cancer
- Keywords
- Enzalutamide, 15-307
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Medivation, Inc., Astellas Pharma Inc
- Study start
- 19 May 2016
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: Enzalutamide, Behavioral: assessment160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1, PR <1 and HER2 0 or 1+ or FISH not amplified if IHC 2+.
- AR testing may be performed while patient is undergoing other adjuvant therapy (i.e., surgery, chemotherapy, radiation).
- Willing and able to provide informed consent. Woman at least 18 years of age.
- Patient is a candidate for treatment of their early stage breast cancer.
- Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1%, PR <1% and HER2 0 or 1+ or FISH not amplified if IHC 2+.
Key exclusion criteria (10 listed)
- Each patient eligible to participate in this study must NOT meet any of the following exclusion criteria.
- Any severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirements.
- Evidence of metastatic/Stage 4 breast cancer
- History of another invasive cancer within 5 years with the exceptions of nonmelanoma skin cancers and AJCC Stage 0 or 1 cancers that have a remote probability of recurrence in the opinion of the investigator
- Absolute neutrophil count < 1500/μL, platelet count < 75,000/μL, or hemoglobin < 9 g/dL (5.6 mmol/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzalutamide | Drug | Enzalutamide |
| assessmentAlso: Functional Assessment of Cancer Therapy-Breast (FACT-B) scale | Behavioural | Enzalutamide |
Primary outcome
The treatment discontinuation rate of enzalutamide in the adherent population
Time frame: 3 years
feasibility
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Traina, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide and assessment in people with Breast Cancer and Early Stage, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment discontinuation rate of enzalutamide in the adherent population (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.