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A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin TM With Herceptin R As First-Line Therapy of Advanced Her-2 Positive Breast Cancer


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

Thank you

Trial Information

A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin TM With Herceptin R As First-Line Therapy of Advanced Her-2 Positive Breast Cancer


Inclusion Criteria:



- Confirmed adenocarcinoma of the breast

- Tumor shows 3+ overexpression of the HER-2/proto-oncogene by immunohistochemistry
assay, or is FISH+

- Stage IV disease

- Measurable disease

- At least 3wks since prior cytotoxic chemotherapy

- At least 4wks since radiotherapy with full recovery

- At least 4wks since major surgery with full recovery

- ECOG performance status 0-2

- At least 18yrs old

- ANC at least 1.5 x 10^9 cells/L

- Platelets at least 100 x 10^9 cells/L

- Hemoglobin at least 9 g/dL

- AST, ALT less than 2.5X upper limit normal

- Alkaline Phosphatase less than 1.5X upper limit normal

- Creatinine less than 1.5 gm/dL

- Normal left ventricular ejection fraction

- Negative pregnancy test

- Agree to use method to avoid pregnancy

- Informed Consent is obtained

Exclusion Criteria:

- Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One
year since Taxane and Herceptin treatment.

- Cumulative life-time dose of doxorubicin is greater than 360 mg/m2

- Concurrent immunotherapy or hormonal therapy

- Parenchymal brain metastases, if present, must be documented to be clinically and
radiographically stable for at least 6 months after treatment

- Serious intercurrent medical or psychiatric illness, including serious active
infection

- History of congestive heart failure

- History of other malignancy within the last 5 years which could affect the diagnosis
or assessment of breast cancer

- Patients who have received an investigational drug within the previous 3 weeks

- Patient is currently enrolled in another clinical study receiving investigational
therapies

- Pregnant or nursing women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients who achieve an objective confirmed complete or partial target lesion response based on the RECIST response criteria.

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Principal Investigator

Andrew Seidman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CA016

NCT ID:

NCT00093145

Start Date:

June 2004

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Advanced Breast Cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Rhode Island HospitalProvidence, Rhode Island  02903
Southwest Regional Cancer CenterAustin, Texas  78705
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Washington Hospital CenterWashington, District of Columbia  20010
Florida Cancer InstituteNew Port Richey, Florida  34652
Breastlink Med GroupLong Beach, California  90806
Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer CenterStamford, Connecticut  06902
Lombardi Cancer Center Georgetown University HospitalWashington, District of Columbia  2007
Gulf Coast Oncology AssociatesSt. Petersburg, Florida  33705
Gerogia Cancer SpecialistAtlanta, Georgia  30341
University of Pittsburgh Medical Center Magee Womens HospitalPittsburgh, Pennsylvania  15213
Swedish Medical Center Cancer Institute ResearchSeattle, Washington  98104