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A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasm

Thank you

Trial Information

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy


This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to
single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression
is noted.


Inclusion Criteria:



- proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable
disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver
and renal function; DLco grade 0 or 1.

Exclusion Criteria:

- HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain
metastases,

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Response

Outcome Description:

Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Joanne L. Blume, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TG-AFP-003

NCT ID:

NCT01233947

Start Date:

May 2011

Completion Date:

August 2012

Related Keywords:

  • Breast Neoplasm
  • Breast Neoplasms
  • Neoplasms

Name

Location
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas, Texas  75246