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A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer

Inclusion Criteria:

1. Female presenting with metastatic breast cancer.

2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.

3. HER2 and HR status must have been determined.

4. Patients must have HER2 negative breast cancer.

5. Patients must have a documented disease progression as define by RECIST at baseline.

6. Patients with HR+ disease:

- Must have received at least one prior endocrine therapy in the metastatic

- Must have received no more than three lines of chemotherapy in the metastatic

7. Patients with HR- disease must have received at least one and no more than three
lines of chemotherapy in metastatic setting.

Exclusion Criteria:

1. Patients with known brain metastases or who have signs/symptoms attributable to brain
metastases and have not been assessed with radiologic imaging to rule out the
presence of brain metastases.

2. Impaired cardiac function or clinically significant cardiac diseases, including any
of the following:

- History or presence of serious uncontrolled ventricular arrhythmias or presence
of atrial fibrillation.

- Clinically significant resting bradycardia (< 50 beats per minute).

- LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition
scanning (MUGA)< 45%.

3. Any of the following within 6 months prior to study entry: myocardial infarction
(MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart
Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA),
Pulmonary Embolism (PE).

4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or
without anti-hypertensive medication.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete responses (CR) or partial response (PR) defined according to RECIST

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

March 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • HER2 negative
  • FGFR1
  • Breast Neoplasms



Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Associates in Oncology/Hematology, P.C.Kensington, Maryland  20895
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Texas Oncology, P.A. Dept. of Texas OncologyBedford, Texas  76022
Cancer Care Associates Medical Group Dept. of CCARedondo Beach, California  90277
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)Fort Myers, Florida  33901
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)Tyler, Texas  75702
UCLA/ University of California Los Angeles Div. of Hematology/OncologyLos Angeles, California  90095
Texas Oncology, P.A. Texas Oncology - SammonsDallas, Texas  75246
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer CareRoanoke, Virginia  24014
Texas Oncology, P.A. AustinBedford, Texas  76022
Texas Oncology, P.A. Presbyterian HospitalDallas, Texas  75246
Comprehensive Blood and Cancer Center Dept CBCC (3)Bakersfield, California  93309
Tower Cancer ResearchBeverly Hills, California  90211
Kansas City Cancer Center KCCC (3)Overland Park, Kansas  66210
UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer CtrChapel Hill, North Carolina  27599-7295
Northwest Cancer Specialists Northwest Office (2)Portland, Oregon  97210
Fairfax Northern Virginia Hematology Oncology Fairfax NVHFairfax, Virginia  22031