Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00580333
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cisplatin — DRUG
    Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
  • bevacizumab — DRUG
    Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel
  • doxorubicin — DRUG
    Postoperative: Given intravenously for four 2-week cycles
  • cyclophosphamide — DRUG
    Postoperative: Given intravenously for four two-week cycles
  • paclitaxel — DRUG
    Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Study Details

The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.

Key Dates

First listed
Dec 24, 2007
Start date
Sep 30, 2007
Status verified
May 2021
Primary completion
Dec 31, 2010
Completion
Jun 30, 2020

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cisplatin/Avastin
    Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

Primary Outcome Measure

Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer. [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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