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Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer



- To determine the 6-month progression-free survival rate of patients with metastatic
breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation,
gemcitabine hydrochloride, and bevacizumab.


- To determine the adverse event profile of this regimen.

- To determine the progression-free survival and overall survival of patients treated
with this regimen.

- To determine the confirmed response rate, duration of response, and time to treatment
failure in patients treated with this regimen.

- To determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV
over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after
completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

Inclusion Criteria


- Histologically or cytologically confirmed infiltrating breast cancer

- Clinical evidence of metastatic disease

- Measurable disease, defined as at least one measurable lesion per RECIST criteria

- No non-measurable disease only, defined as all other lesions, including small
lesions (longest diameter < 2 cm) and truly non-measurable lesions, including
any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Patients with HER-2/neu positive tumors, must have received prior treatment with
trastuzumab (Herceptin®) or have a contraindication for trastuzumab

- No evidence of active brain metastasis, including leptomeningeal involvement, on MRI
or CT scan

- CNS metastasis controlled by prior surgery and/or radiotherapy allowed

- Must be asymptomatic for ≥ 2 months with no evidence of progression prior
to study entry

- Hormone receptor status not specified


- Menopausal status not specified

- Life expectancy ≥ 12 weeks

- ECOG performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Total bilirubin ≤ 1.5 times ULN

- Creatinine ≤ 1.5 mg/dL

- Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein

- Patients discovered to have ≥ 1+ proteinuria at baseline must demonstrate
24-hour urine protein < 1 g

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study therapy

- Able to complete questionnaires alone or with assistance

- No peripheral neuropathy > grade 1

- No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel,
gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or
chemically similar agents

- No stage III or IV invasive, non-breast malignancy within the past 5 years

- No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of
the cervix

- Patient must not be receiving other specific treatment for a prior malignancy

- No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2
occasions at least 5 minutes apart)

- Patients who have recently started or adjusted antihypertensive medications are
eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3
different observations in ≥ 14 days

- No bleeding diathesis or uncontrolled coagulopathy

- No hemoptysis within the past 6 months

- No prior arterial or venous thrombosis within the past 12 months

- No history of cerebrovascular accident

- No history of hypertensive crisis or hypertensive encephalopathy

- No abdominal fistula or gastrointestinal perforation within the past 6 months

- No serious non-healing wound, ulcer, or fracture

- No clinically significant cardiac disease, defined as any of the following:

- Congestive heart failure

- Symptomatic coronary artery disease

- Unstable angina

- Cardiac arrhythmias not well controlled with medication

- Myocardial infarction within the past 12 months

- No comorbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for study entry or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens


- See Disease Characteristics

- No prior chemotherapy for metastatic disease

- May have received one prior adjuvant chemotherapy regimen

- Prior neoadjuvant chemotherapy allowed

- More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel
or paclitaxel) therapy

- Prior hormonal therapy in either adjuvant or metastatic setting allowed

- More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or
single dose radiation for palliation)

- Prior radiotherapy to a target lesion is allowed provided there has been clear
progression of the lesion since radiotherapy was completed

- More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational

- More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants,
or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)

- More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy

- More than 1 week since prior minor surgery (e.g., core biopsy)

- Placement of a vascular access device within 7 days is allowed

- More than 3 months since prior neurosurgery

- No concurrent treatment in a different clinical study in which investigational
procedures are performed or investigational therapies are administered

- Trials related to symptom management (Cancer Control) which do not employ
hormonal treatments or treatments that may block the path of the targeted agents
used in this study may be allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival (PFS) rate

Safety Issue:


Principal Investigator

Donald W. Northfelt, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



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Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
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