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A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer

Inclusion Criteria:

- Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio
of <2.0 or IHC <1+) metastatic breast cancer. Locally advanced or recurrent disease
is also eligible.

- Patients must have measurable disease

- Patients must not have received prior chemotherapy for metastatic breast cancer (not
including adjuvant therapy). Patients should be > 4 weeks from their most recent
chemotherapy or radiation therapy treatment.

- Age >18 years

- ECOG performance status <1 (Karnofsky >80%).

- Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count >1,500/uL

- platelets >100,000/uL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal

- creatinine within normal institutional limits OR creatinine clearance>60 mL/min/1.73
m2 for patients with creatinine levels above institutional normal

- PT INR < 1.5 (Unless patient is on anticoagulation)

- urine protein <1+

- Tissue from the primary tumor must be available for correlative studies

- Women of child-bearing potential must agree to use adequate contraception

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not

- Patients may not be receiving any other investigational agents.

- Patients with known brain metastases will be excluded

- Patients may have had prior radiation therapy, provided the patient has measurable
disease and there has been clear progression since the completion of radiation
therapy. Patients who have had radiotherapy within 4 weeks prior to entering the
study or those who have not recovered from adverse events due to therapy administered
more than 4 weeks earlier will be excluded.

- Patients with significant cardiac dysfunction will be excluded

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study, breastfeeding should be discontinued.

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with carboplatin or the
other agents administered during the study.

- Patients with evidence of bleeding diathesis or coagulopathy.

- Patients with inadequately controlled hypertension will be excluded

- Patients who have had a stroke or TIA within 6 months of registration will be

- Patients with a history of hypertensive crisis or hypertensive encephalopathy will be

- Patients with a history of abdominal fistula, GI perforation, or intra-abdominal
abscess within 6 months of registration.

- Patient with history of serious non-healing wound, ulcer or bone fracture.

- Patients with major surgery, open biopsy, or significant traumatic injury within 28
days of registration or anticipated need for surgery during course of study

- Patients with a history core biopsy or other minor surgery, excluding venous access
device (VAD) placement, within 7 days of registration.

- Patients with active second malignancy.

- Known hypersensitivity to any component of bevacizumab (AvastinĀ®).

- Peripheral neuropathy > Grade 1.

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:

progression free survival

Outcome Time Frame:

indefinite (subjects will be followed until disease progression)

Safety Issue:


Principal Investigator

Rita Nanda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

April 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



University of Chicago Chicago, Illinois  60637
Oncology Specialists Park Ridge, Illinois  60068