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A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer


For additional information on this trial, please call (910) 558-2913

Inclusion Criteria:



- Subjects with locally advanced or metastatic Her-2-positive breast cancer who have
failed at least one trastuzumab containing regimen. Prior treatment with other
Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed

- Histologic or cytologic diagnosis of Her-2-positive breast cancer

- ECOG status 0 - 1

Exclusion Criteria:

- Symptomatic brain metastasis

- Any condition requiring chronic use of steroids

- Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2
Diabetes Mellitus or prediabetic symptoms

- History of glucose intolerance

- Women of child-bearing potential unwilling or unable to use acceptable contraception
methods

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis

Outcome Time Frame:

Every 30 days until MTD is reached

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CA191-004

NCT ID:

NCT00788333

Start Date:

July 2009

Completion Date:

November 2011

Related Keywords:

  • Breast Cancer
  • Advanced or Metastatic Her-2-positive Breast Cancer
  • Breast Neoplasms

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