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Trial record 1 of 1 for:    NCT01889238
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Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT01889238
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Results First Posted : August 22, 2018
Last Update Posted : January 20, 2023
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

Condition or disease Intervention/treatment Phase
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer Drug: Enzalutamide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER
Actual Study Start Date : June 12, 2013
Actual Primary Completion Date : March 1, 2015
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
 Drug: Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Other Names:
  • Xtandi®
  • MDV3100


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population [ Time Frame: Week 16 ]
    Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >= 16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference

  2. Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population [ Time Frame: Week 16 ]
    Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.


Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population [ Time Frame: Week 24 ]
    Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

  2. Percentage of Participants With Clinical Benefit at Week 24: ITT Population [ Time Frame: Week 24 ]
    Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

  3. Percentage of Participants With Best Objective Response: Evaluable Population [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]
    Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.

  4. Percentage of Participants With Best Objective Response: ITT Population [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]
    Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.

  5. Progression-Free Survival (PFS): Evaluable Population [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]
    PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.

  6. Progression-Free Survival: ITT Population [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]
    PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.


Other Outcome Measures:
  1. Trough Plasma Concentration of Enzalutamide and Its Metabolite, [ Time Frame: Predose on Day 1 (Baseline), Week 9 and Week 17 ]
    M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/ml) for enzalutamide and M2.

  2. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 87 weeks ]
    An AEs was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 87 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

  3. Number of Participants With Study Drug Discontinuation Due to Adverse Events [ Time Frame: Baseline up to 87 weeks ]
  4. Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Baseline up to 87 weeks ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure.

  5. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 87 weeks ]
    Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit or 2 consecutive visits SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 subject had data were reported.

  6. Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades [ Time Frame: Baseline up to 87 weeks ]
    Laboratory tests included hematology parameters (low lymphocytes, WBC, neutrophils, hemoglobin and platelets) and chemistry parameters (mean albumin, Blood urea nitrogen [BUN], calcium, Lactate dehydrogenase [LDH], alanine aminotransferase, Aspartate aminotransferase , bilirubin, Alkaline phosphatase, creatinine and glucose). Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per National Cancer Institute Common Terminology Criteria (NCI CTC) (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women at least 18 years of age;
  • Advanced AR+ TNBC;
  • Availability of a representative tumor specimen:
  • Either measurable disease or bone only nonmeasurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Any severe concurrent disease, infection, or comorbid condition;
  • Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
  • Current or previously treated brain metastasis or active leptomeningeal disease;
  • Current hormone replacement therapy;
  • Local palliative radiation therapy within 7 days before day 1;
  • History of another invasive cancer within 5 years of day 1;
  • Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
  • Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Active gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks before day 1;
  • Treatment with any commercially available anticancer agent within 14 days before day 1;
  • Treatment with any investigational agent within 2 weeks before day 1;
  • Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
  • Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01889238


Locations
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Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Study Chair: Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01889238    
Other Study ID Numbers: MDV3100-11
2013-000698-57 ( EudraCT Number )
C3431007 ( Other Identifier: Alias Study Number )
First Posted: June 28, 2013    Key Record Dates
Results First Posted: August 22, 2018
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
breast cancer
triple negative
androgen receptor positive
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases