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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Advanced, Androgen Recpetor Positive Triple Negative Breast Cancer

Thank you

Trial Information

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


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 ULN or an estimated creatinine clearance < 50 mL/minute
calculated using the Cockcroft Gault equation 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Rate

Outcome Description:

To determine clinical benefit rate, defined as the proportion of evaluable patients with androgen receptor positive (AR+), triple negative breast cancer (TNBC) with a best response of complete response (CR), partial response (PR), or stable disease (SD) ≥ 16 weeks.

Outcome Time Frame:

≥ 16 weeks

Safety Issue:

No

Principal Investigator

Amy Peterson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medivation, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MDV3100-11

NCT ID:

NCT01889238

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Advanced, Androgen Recpetor Positive Triple Negative Breast Cancer
  • breast cancer
  • triple negative
  • androgen receptor positive
  • Breast Neoplasms

Name

Location

Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
McLean, Virginia  22101
Hackensack, New Jersey  07601