Trial record 2 of 34 for:    astellas medivation

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Astellas Pharma Inc
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT02091960
First received: March 18, 2014
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in subjects with HER2+ AR+ and ER- metastatic or locally advanced breast cancer.


Condition Intervention Phase
Advanced Breast Cancer
Human Epidermal Growth Factor Receptor 2 (HER2)
HER2 Amplified
Drug: enzalutamide
Drug: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Clinical benefit rate (CBR) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Defined as proportion of evaluable subjects with best objective response of complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria


Secondary Outcome Measures:
  • Overall response rate (CR+PR) according to RECIST 1.1 criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Best overall response rate according to RECIST 1.1 criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Defined as the time from the date of first dose of enzalutamide (Study Day 1) until the date of disease progression per RECIST 1.1, or death from any cause on study, whichever occurs first

  • Time to progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1

  • Duration of response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression

  • Time to response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Defined as the time from the first date of enzalutamide treatment to initial CR or PR

  • Safety assessed by physical examinations, vital signs, laboratory assessments, electrocardiograms, left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition scan (MUGA), and evaluation of adverse events [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide and Trastuzumab Drug: enzalutamide
oral
Other Names:
  • Xtandi,
  • MDV3100
Drug: trastuzumab
Intravenous infusion (IV)
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+
  • The subject has AR+ and ER-/PgR- breast cancer
  • The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment
  • The subject has measurable disease according to RECIST 1.1
  • The subject has received at least 1 but no more than 4 lines of therapy in the metastatic or locally advanced disease (a line of therapy is defined as a course of treatment, at the end of which there was disease progression)
  • 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
  • The subject has an estimated life expectancy of at least 6 months at Day 1
  • The subject must be able to swallow study drug and comply with study requirements
  • The subject agrees not to participate in another interventional study while on treatment

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 inadequate marrow, hepatic, and/or renal function.
  • 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 has clinically significant cardiovascular disease.
  • The subject has significant respiratory disease, including severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
  • The subject has an active gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease) within the 3 months prior to the Day 1 visit.
  • 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.
  • The subject has been treated with any investigational drugs within 14 days prior to the Day 1 visit.
  • The subject has received treatment with any approved or investigational agent that either blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, bicalutamide, enzalutamide, TAK-448, TAK-683, TAK-700, ARN-509, ODM-201, BMS-641988). Subjects who received treatment for <28 days or placebo on an investigational study are acceptable.
  • The subject received pertuzumab in the most recent line of therapy.
  • The subject has a known history of positive test for Hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV).
  • The subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the enzalutamide capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene.
  • The subject has had a severe infusion reaction to trastuzumab or hypersensitivity to trastuzumab, and excipients including murine proteins, L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dehydrate, L-methionine, and polysorbate.
  • The subject has any other condition or reason that would make the subject ineligible to receive trastuzumab, interferes with the ability of the subject to participate in the trial, places the subject at undue risk, or complicates the interpretation of safety data.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091960

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

Locations
United States, California
Pacific Cancer Medical Center Recruiting
Anaheim, California, United States, 92801
East Valley Hematology Oncology Medical Group Recruiting
Burbank, California, United States, 91505
The Oncology Institute of Hope and Innovation Recruiting
Whittier, California, United States, 90603
United States, Colorado
Univ of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Florida Cancer Specialists Recruiting
St.Petersberg, Florida, United States, 33705
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
United States, Texas
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
Canada, Ontario
Sault Area Hospital Recruiting
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT02091960     History of Changes
Other Study ID Numbers: 9785-CL-1121, 2013-000093-29
Study First Received: March 18, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Ireland: Irish Medicines Board
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Breast cancer
Enzalutamide
Xtandi
Androgen receptor positive
HER2
Trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Trastuzumab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014