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A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer

If you take part in this research study, you will be given a study drug-dosing calendar for
each treatment cycle. Each treatment cycle lasts 3 weeks during which time you will be
taking the study drug twice daily for 21 days. During all cycles you will have a physical
exam and will be asked questions about your general healthy and specific questions about any
problems that you might be having and any medications you may be taking. Physical exams will
occur in clinic on screening, day 15, day 29, day 43 and every two weeks.

After the final dose of the study drug your research doctor will ask you to visit the office
for a follow-up exam approximately 30 to 37 days after discontinuing therapy. At this visit
you will have a physical exam, vital signs, blood tests and be asked about any symptoms you
may be experiencing since stopping ARQ 197. You will be followed approximately every 6
months after removal from the study.

Inclusion Criteria:

- Histologically or cytologically confirmed, triple-negative (ER-, PR-, HER2-) invasive
breast cancer with recurrent or metastatic disease

- Measurable disease

- Must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer m

- Must have been off treatment with chemotherapy, biologic therapy, investigational
therapy and radiation therapy for at least 14 days before enrollment in the study

- ECOG performance status of less than or equal to 2

- Either the primary tumor or the metastasis must be triple-negative

- Confirmed availability of FFPE tumor tissue

Exclusion Criteria:

- Pregnant or breastfeeding

- Have received treatment within the past 14 days

- Known brain metastases that are untreated, symptomatic or require therapy to control

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ARQ197

- History of congestive heart failure, active coronary artery disease, uncontrolled
hypertension, myocardial infarction within 6 months

- Uncontrolled intercurrent illness

- HIV positive on combination antiretroviral therapy

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate the Activity of ARQ-197

Outcome Description:

Evaluate the activity of ARQ-197, as defined as by 6-month Progression Free Survival (PFS) in Participants with triple-negative metastatic breast cancer.

Outcome Time Frame:

Patients will be followed until disease progression

Safety Issue:


Principal Investigator

Sara Tolaney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Recurrent
  • Metastatic
  • Breast Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Dana-Farber Cancer Institute at Faulkner Hospital Boston, Massachusetts  02215