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Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib


Phase 2
N/A
N/A
Open (Enrolling)
Both
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage IV Breast Cancer, Triple-negative Breast Cancer

Thank you

Trial Information

Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib


PRIMARY OBJECTIVE:

I. The primary objective is progression free survival.

SECONDARY OBJECTIVES:

I. Response rate. II. Overall survival. III. Safety and toxicity. IV. Exploratory biomarkers
will be assessed as potential predictors of response to treatment including: expression of
epidermal growth factor receptor (EGFR) and secreted protein acidic and rich in cysteine
(SPARC) in the primary tumor and changes in levels of circulating tumor cells (CTCs) and
circulating endothelial cells (CECs).

OUTLINE:

INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation
intravenously (IV) once weekly for 24 weeks and bevacizumab IV over 30-90 minutes once every
2 weeks for 24 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable
disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes
once every 2 weeks and erlotinib hydrochloride orally (PO) once daily (QD) in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up per physician discretion.


Inclusion Criteria:



- Have histologically confirmed invasive breast cancer that is estrogen receptor (ER)
negative, progesterone receptor (PR) negative and human epidermal growth factor
receptor (HER)-2 non-overexpressing

- Be receiving first-line therapy for metastatic disease

- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria;
Xrays, scans or physical examinations used for tumor measurement must have been
completed within 28 days prior to registration; Xrays, scans or other tests for
assessment of non-measurable disease must have been performed within 42 days prior to
registration

- OR Non-measurable disease only, with rising serum CA15-3 or CA 27.29 or
carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at
least 14 days apart with the most recent measurement being within 42 days prior to
registration

- AND the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase
over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or
for CEA be greater than or equal to 4 ng/mL

- If of childbearing potential must have a negative pregnancy test and use an effective
method to avoid pregnancy for the duration of the trial and for at least 6 months
after completion of study therapy if able to bear children

- Patients must be informed of the investigational nature of this study and must sign
and give informed consent in accordance with institutional standards and federal
guidelines

Exclusion Criteria

- Recurrent disease within 12 months after completion of adjuvant chemotherapy
containing a weekly taxane

- Central nervous system (CNS) metastases

- Pre-existing nephritic syndrome

- Serious intercurrent medical or psychiatric illness including serious active
infection

- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or
diastolic blood pressure > 100 mmHg on antihypertensive medications)

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study
enrollment

- History of stroke or transient ischemic attack within 6 months prior to study
enrollment

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening as demonstrated by either: urine protein:creatinine (UPC)
ratio >= 1.0 at screening OR urine dipstick for proteinuria >= 2+ (patients
discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should
undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours
to be eligible)

- Known hypersensitivity to any component of bevacizumab

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.

Outcome Time Frame:

Baseline, every 8 weeks and at follow up

Safety Issue:

No

Principal Investigator

Jennifer Specht

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6628

NCT ID:

NCT00733408

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Stage IV Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms

Name

Location

Providence Alaska Medical CenterAnchorage, Alaska  99508
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Bozeman Deaconess HospitalBozeman, Montana  59715
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Katmai Oncology GroupAnchorage, Alaska  99508-4627
Cascade Cancer CenterKirkland, Washington  98034-3013
Evergreen Hospital Medical CenterKirkland, Washington  98033
Multicare Health SystemTacoma, Washington  98415
Overlake Hospital Medical CenterBellevue, Washington  98004
St. Joseph Regional Medical CenterLewiston, Idaho  83501
Skagit Valley Hospital Regional Cancer Care CenterMount Vernon, Washington  98274
Olympic Medical Cancer Care CenterSequim, Washington  98384
Anchorage Oncology CenterAnchorage, Alabama  
Northwest Healthcare: Kalispell Regional Medical CenterKallispell, Alabama  
Overlake Cancer CenterBellevue, Washington  
Columbia Basin Hematology & Oncology PLLCKennewick, Washington  99336