ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110084
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : May 26, 2011
Last Update Posted : June 2, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

May 3, 2005
May 4, 2005
March 29, 2011
May 26, 2011
June 2, 2011
August 2005
May 2010   (Final data collection date for primary outcome measure)
Proportion of Patients With Confirmed Responses [ Time Frame: Two consecutive evaluations at least 6 weeks apart ]

Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.

Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.

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Complete list of historical versions of study NCT00110084 on Archive Site
  • Progression-free Survival [ Time Frame: Time from registration to progression or death (up to 5 years) ]
    Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
  • Overall Survival [ Time Frame: Death or last follow-up (up to 5 years) ]
    Overall survival time was defined as the number of days from registration to the date of death or last follow-up
  • Adverse Event [ Time Frame: Every 6 weeks ]
    Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
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ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.



  • Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.
  • Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.


* Determine the time to disease progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Gemcitabine
    1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
    Other Name: Gemzar
  • Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
    125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
    Other Name: nab (nanoparticle albumin-bound)-Paclitaxel, Abraxane
Experimental: Nab-paclitaxel/Gemcitabine
  • Drug: Gemcitabine
  • Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2010
May 2010   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed invasive breast cancer

    - Clinical evidence of metastatic disease

    + No bone metastases or other non-measurable disease as the only evidence of metastasis

  • Measurable disease, defined as at least 1 measurable lesion

    - The following are considered non-measurable disease:

    • Small lesions (< 2 cm)
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural or pericardial effusions
    • Inflammatory breast disease
    • Lymphangitis cutis or pulmonis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
  • HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab
  • No evidence of active brain metastasis, including leptomeningeal involvement
  • Hormone receptor status:

    • Not specified



  • 18 and over Sex
  • Female Menopausal status
  • Not specified Performance status
  • ECOG 0-1 Life expectancy
  • At least 12 weeks Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL Hepatic
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN Renal
  • Creatinine ≤ 1.5 mg/dL Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • No pre-existing peripheral neuropathy > grade 1
  • No other clinically significant illness or significant medical condition that would preclude study participation
  • No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs
  • No serious medical risk factors involving any of the major organ systems that would preclude study participation
  • No active stage III or IV invasive non-breast malignancy within the past 5 years


Biologic therapy

  • See Disease Characteristics Chemotherapy
  • No more than 1 prior adjuvant chemotherapy regimen
  • No prior chemotherapy for metastatic disease
  • At least 6 months since prior adjuvant or neoadjuvant taxane
  • More than 2 weeks since prior cytotoxic chemotherapy
  • Prior neoadjuvant chemotherapy allowed
  • No other concurrent chemotherapy Endocrine therapy
  • Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy
  • Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment
  • More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy
  • No concurrent radiotherapy Surgery
  • Not specified Other
  • More than 2 weeks since prior investigational drugs
  • No concurrent participation in another clinical trial that is studying investigational procedures or therapies
  • Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U10CA025224 ( U.S. NIH Grant/Contract )
N0531 ( Other Identifier: Mayo Clinic Cancer Cancer and NCCTG )
855-05 ( Other Identifier: Mayo Clinic IRB )
N0433 ( Other Identifier: NCCTG Old Protocol )
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Vivek Roy, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Vivek Roy, MD, FACP Mayo Clinic
Study Chair: Philip J. Stella, MD CCOP - Michigan Cancer Research Consortium
Principal Investigator: Tom R. Fitch, M.D. Mayo Clinic
Principal Investigator: Timothy J. Hobday, M.D. Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP