A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

NCT02091960

Last updated date
Study Location
Site US10051
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+

- The subject has AR+ breast cancer

- The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment

- The subject has measurable disease or nonmeasurable, evaluable disease per RECIST 1.1. (NOTE: pleural effusions, ascites or other third fluid space are not evaluable diseases per RECIST 1.1).

- The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.

- The subject has adequately recovered from toxicities due to prior therapy.

- The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ≤ 1 at Screening and Day 1

- The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- The subject has a severe concurrent disease, infection, or comorbidity that would make
the subject inappropriate for enrollment.


- The subject has current or previously treated brain metastasis or active
leptomeningeal disease. Brain imaging is required during screening in all subjects to
exclude the presence of unequivocal central nervous system disease.


- The subject has a history of a non-breast cancer malignancy with the following
exceptions:


- The subject with a previous history of a non-invasive carcinoma is eligible if
he/she has had successful curative treatment any time prior to Screening.


- For all other malignancies, the subject is eligible if they have undergone
potentially curative therapy and they have been considered disease free for at
least 5 years prior to Screening.


- The subject has a history of seizure or any condition that may predispose to seizure
(e.g., prior cortical stroke, significant brain trauma).


- The subject has a history of loss of consciousness, cerebrovascular accident, or
transient ischemic attack within 12 months before the Day 1 visit.


- The subject has had a hypoglycemic episode requiring medical intervention while on
insulin (or other anti-diabetic) treatment within 12 months before Day 1.


- The subject had a major surgical procedure, substantial open biopsy, or significant
traumatic experience within 28 days before the Day 1 visit, or anticipation of need
for major surgical procedure during the course of the study.


- The subject has had palliative radiation therapy to bone metastases within 14 days
prior to the Day 1 visit (side effects from radiation must be resolved).


- The subject has received chemotherapy, immunotherapy, or any other systemic anticancer
therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days
prior to the Day 1 visit.

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HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
NCT02091960
  1. Anaheim, California
  2. Los Angeles, California
  3. San Francisco, California
  4. Fort Myers, Florida
  5. Gainesville, Florida
  6. Chicago, Illinois
  7. Indianapolis, Indiana
  8. Boston, Massachusetts
  9. Saint Louis, Missouri
  10. Cincinnati, Ohio
  11. Pittsburgh, Pennsylvania
  12. Knoxville, Tennessee
  13. Nashville, Tennessee
  14. Nashville, Tennessee
  15. Fort Worth, Texas
  16. Houston, Texas
  17. Edegem, Antwerp
  18. Brasschaat,
  19. Bruxelles,
  20. Charleroi,
  21. Leuven,
  22. Liege,
  23. Ottawa, Ontario
  24. Toronto, Ontario
  25. Regina, Saskatchewan
  26. Saskatoon, Saskatchewan
  27. Quebec,
  28. Meldola, Forli
  29. Lecce,
  30. Milano,
  31. Milan,
  32. Sondrio,
  33. Udine,
  34. Pozuelo de Alarcon, Madrid
  35. Barcelona,
  36. Madrid,
  37. Edinburgh,
  38. Manchester,
  39. Nottingham,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
Official Title  ICMJE A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer
Brief Summary The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2 Amplified
  • Advanced Breast Cancer
  • Human Epidermal Growth Factor Receptor 2 (HER2)
Intervention  ICMJE
  • Drug: Enzalutamide
    Capsules for oral administration
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Trastuzumab
    Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country
    Other Name: Herceptin
Study Arms  ICMJE Experimental: Enzalutamide + Trastuzumab
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
Interventions:
  • Drug: Enzalutamide
  • Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
103
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2014)
80
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+
  • The subject has AR+ breast cancer
  • The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment
  • The subject has measurable disease or nonmeasurable, evaluable disease per RECIST 1.1. (NOTE: pleural effusions, ascites or other third fluid space are not evaluable diseases per RECIST 1.1).
  • The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.
  • The subject has adequately recovered from toxicities due to prior therapy.
  • The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ? 1 at Screening and Day 1
  • The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ? 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report

Exclusion Criteria:

  • The subject has a severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment.
  • The subject has current or previously treated brain metastasis or active leptomeningeal disease. Brain imaging is required during screening in all subjects to exclude the presence of unequivocal central nervous system disease.
  • The subject has a history of a non-breast cancer malignancy with the following exceptions:

    • The subject with a previous history of a non-invasive carcinoma is eligible if he/she has had successful curative treatment any time prior to Screening.
    • For all other malignancies, the subject is eligible if they have undergone potentially curative therapy and they have been considered disease free for at least 5 years prior to Screening.
  • The subject has a history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma).
  • The subject has a history of loss of consciousness, cerebrovascular accident, or transient ischemic attack within 12 months before the Day 1 visit.
  • The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1.
  • The subject had a major surgical procedure, substantial open biopsy, or significant traumatic experience within 28 days before the Day 1 visit, or anticipation of need for major surgical procedure during the course of the study.
  • The subject has had palliative radiation therapy to bone metastases within 14 days prior to the Day 1 visit (side effects from radiation must be resolved).
  • The subject has received chemotherapy, immunotherapy, or any other systemic anticancer therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days prior to the Day 1 visit.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02091960
Other Study ID Numbers  ICMJE 9785-CL-1121
2013-000093-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame:Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Executive Medical DirectorAstellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP