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Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer

NCT01288261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-04-21

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer

Conditions

  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Interventions

DRUG

paclitaxel

Given IV

BIOLOGICAL

bavituximab

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative study

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Alison Stopeck · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288261 on ClinicalTrials.gov