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A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients With Metastatic Breast Cancer

Phase 3
16 Years
Not Enrolling
Breast Neoplasms, Metastases, Neoplasm

Thank you

Trial Information

A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients With Metastatic Breast Cancer

Taxol (Bristol-Meyers Squibb) is active against carcinomas of the ovary, breast, lung,
esophagus and head and neck. A number of dose schedules of Taxol have been tested in breast
cancer. Initial trials used 250 mg/m2 as a continuous infusion over 24 hours.
Subsequently, shorter infusions of Taxol over three hours were tested at a dose of 175
mg/m2, with response rates of 30%-40%. Phase II studies using higher doses of Taxol at
200-250 mg/m2 had a response rate of 56% in metastatic breast cancer patients. However, at
these doses, significant toxicities occurred, including neuropathy. There was a median
granulocyte count nadir at 100-200 cells/mm3 for the majority of courses administered.
There were also significant side effects associated with hypersensitivity to the Taxol
vehicle, Cremophor-EL. These hypersensitivity reactions require a premedication schedule
that includes a corticosteroid, an H2 antagonist and an antihistamine.

Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor. This
formulation is a protein-stabilized, nanoparticle suspension of paclitaxel and human serum
albumin in normal saline. The potential advantages of this formulation are:

- Higher tolerated doses, with greater efficacy

- Longer drug persistence in tumor as a result of the nanoparticle formulation

- Reduced infusion time

- Reduced risk of hypersensitivity with no required premedication schedule

- More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data

This study will evaluate ABI-007, as compared to Taxol, in patients with metastatic breast

Inclusion Criteria

Patients will be eligible for this trial if:

- Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a
negative serum pregnancy test, and use approved contraception

- Sixteen years of age or older

- Histologically or cytologically confirmed breast cancer (stage III or IV) with
evidence of inoperable local recurrence or metastasis, with measurable disease

- If patient has received taxane therapy as an adjuvant he/she has not relapsed within
one year of completing adjuvant taxane

- No other malignancy present within the past 5 years, except non-melanoma skin cancer,
cervical intraepithelial neoplasia or in-situ cervical cancer

- Suitable candidate for paclitaxel therapy

- Hematology levels at baseline of: absolute neutrophil count of at least 1500
cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9

- Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the
upper limit of normal, if no evidence of liver metastasis; total bilirubin of less
than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline
phosphatase of less than or equal to 5 x the upper limit of normal, unless there is
bone metastasis but not liver metastasis

- Expected survival of at least 12 weeks

- Patient or his/her representative has signed an informed consent form

Type of Study:


Study Design:

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

Principal Investigator

Michael J Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Metastases, Neoplasm
  • Metastatic breast cancer
  • Taxol
  • Taxane
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis



Abraxis Bioscience, Inc Durham, North Carolina  27703