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A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer

This is an open-label, randomized study to compare the following regimens with respect to
toxicity and antitumor activity: the MTD of ABI 007 for a q3w schedule (300 mg/m2 every 3
weeks); ABI-007 100 mg/m2 administered weekly for 3 weeks with a 1 week rest; ABI-007 150
mg/m2 administered weekly for 3 weeks with a 1 week rest; and the standard dose and schedule
of Taxotere (100 mg/m2 every 3 weeks).

Inclusion Criteria:

- Pathologically confirmed adenocarcinoma of the breast.

- No prior chemotherapy for metastatic breast cancer.

- Stage IV disease

- Measurable disease

- At least 3 weeks since prior cytotoxic chemotherapy(patients should have recovered
from all acute effects of such therapy.

- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must
be completely outside the radiation portal or there must be radiologic or clinical
exam proof of progressive disease within the radiation portal.

- At least 4 weeks since major surgery, with full recovery.

- ECOG performance status 0-2.

- Age ≥18 years.

- Patient has the following blood counts at Baseline:

- ANC ≥1.5 x 109 cells/L;

- Platelets ≥100 x 109 cells/L

- Hgb ≥9 g/dL.

- Patient has the following blood chemistry levels at Baseline:

- AST (SGOT), ALT (SGPT)≥2.5x upper limit of normal range (ULN);

- Total bilirubin normal;

- Alkaline phosphatase ≥2.5x ULN (unless bone metastasis is present in the absence of
liver metastasis);

- Creatinine ≥1.5 mg/dL.

- Peripheral neuropathy Grade 0 or 1.

- If female of childbearing potential, pregnancy test is negative (within 72 hours of
the first dose of study drug).

- If fertile, the patient agrees to use an effective method to avoid pregnancy for the
duration of the study.

- Informed consent has been obtained

Exclusion Criteria:

- Prior neo-adjuvant or adjuvant chemotherapy is allowed. No prior chemotherapy for
metastatic disease is allowed. If a taxane was part of the adjuvant regimen, at least
one year should have transpired since completion of taxane regimen.

- Cumulative life-time dose of doxorubicin >360 mg/m2. Doxorubicin is allowed as prior
neo-adjuvant or adjuvant therapy but not for metastatic disease.

- Concurrent immunotherapy or hormonal therapy for breast cancer.

- Parenchymal brain metastases, unless documented to be clinically and radiographically
stable for at least 6 months after treatment.

- Serious intercurrent medical or psychiatric illness, including serious active

- History of class II-IV 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 a different clinical study in which investigational
procedures are performed or investigational therapies are administered. Also, a
patient may not enroll in such clinical trials while participating in this study.

- Pregnant or nursing women

- Patients with prior hypersensitivity to both Taxol and Taxotere.

Type of Study:


Study Design:

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

Outcome Measure:

Percentage of patients who achieve PR/CR based on RECIST

Outcome Time Frame:

Treatment duration

Safety Issue:


Principal Investigator

Jose Iglesias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

January 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms