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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gemcitabine Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
Study Start Date : August 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Nab-paclitaxel/Gemcitabine 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110084

  Show 201 Study Locations
Sponsors and Collaborators
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

Publications of Results:
Responsible Party: Vivek Roy, M.D., Mayo Clinic Cancer Center Identifier: NCT00110084     History of Changes
Other Study ID Numbers: CDR0000423195
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 )
First Posted: May 4, 2005    Key Record Dates
Results First Posted: May 26, 2011
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by Mayo Clinic:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs