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An Open-Label, Phase II Study of Weekly ABI-0007 as First Line Therapy for Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

An Open-Label, Phase II Study of Weekly ABI-0007 as First Line Therapy for Patients With Metastatic Breast Cancer

Inclusion Criteria:

- Females with pathologically confirmed adenocarcinoma of the breast.

- No prior chemotherapy for metastatic breast cancer

- At least 12 months between completion of adjuvant chemotherapy and the diagnosis of
metastatic disease

- Stage IV disease

- Measurable disease (must be equal or greater to 2.0cm using conventional CT or equal
or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well
documented on conventional CT scan which must be equal or greater than 1.0 cm)

- 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 equal or greater to 18

- Patients has the following blood counts at Baseline:

- ANC equal or greater to 1.5 x 10^9 cells/L

- Platelets equal or greater to 100 x 10^9 cells/L

- Hgb equal or greater to 90 grams/L

- Patients has the following blood chemistry levels at Baseline:

- AST (SGOT), ALT (SGPT)less than or equal to 2.5x upper limit of normal range (ULN);

- total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease);

- alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present
in the absence of liver metastasis);

- creatinine less than or equal to 1.5mg/dL

- Current sensory neuropathy Grade 0 or 1 by BCI CTCAE

- 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 of contraception to avoid
pregnancy for the duration of the study

- Patient is able to supply unstained slides or 1 tumor block of her primary breast
tumor or a biopsy of a current site of metastasis for SPARC analysis

- Informed consent has been obtained

Exclusion Criteria:

- Concurrent immunotherapy or hormonal therapy (other than Herceptin) 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 diagnoses
or assessment of breast cancer, with the exception of basal or squamous cell
carcinoma of the skin or carcinoma in situ of the cervix

- 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 Taxol or Taxotere

Type of Study:


Study Design:

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

Outcome Measure:

to determine the toxicity and anti tumor activity of ABI-007

Outcome Time Frame:

every cycle

Safety Issue:


Principal Investigator

Sasha Smiljanik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lions Gate Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer, ABI-007, Abraxane
  • Breast Neoplasms