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Completed

NCT Number: NCT00608972

Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer

The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cooper Hospital/University Medical Center, Camden, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
  • Age >= 18
  • ECOG performance status <= 2
  • Normal organ and marrow function
  • Normal cardiac function as evidenced by LVEF within institutional normal limits

Exclusion criteria

  • History of hypersensitivity reactions to doxil or bevacizumab
  • Myocardial infarct or unstable angina within 6 months before enrollment
  • Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
  • Proteinuria

Treatment and study plan

Doxil

Drug

Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.

carboplatin

Drug

Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.

Bevacizumab

Drug

Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.

Other names: Avastin

Primary outcomes

  1. Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer

    Time frame: Two Years

Secondary outcomes

  1. Clinical Benefit Rate (CBR=CR+PR+SD)

    Time frame: up to two years

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  2. One-year Progression-free Survival

    Time frame: one year

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  3. Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative

    Time frame: From date of randomization up to two years

    median overall survival

  4. Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative

    Time frame: six months

    Six-month survival rate

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2008
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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