Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

September 21, 2016 updated by: VASSILIKI SXOINA, Hellenic Oncology Research Group

Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
      • Athens, Greece
        • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital of Athens
      • Athens, Greece
        • Air Forces Military Hospital of Athens
      • Athens, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
      • Heraklion, Greece
        • University Hospital of Crete
      • Larissa, Greece
        • State General Hospital of Larissa, Dep of Medical Oncology
      • Thessaloniki, Greece
        • "Diabalkaniko" hospital, Thessaloniki
      • Thessaloniki, Greece
        • : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast adenocarcinoma
  • No HER2 overexpression or gene amplification
  • Absent or low ER or PR expression
  • No previous therapy for metastatic breast cancer is allowed
  • Age 18-75 years
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
  • adequate renal function (serum creatinine <1.5 times the upper normal limit)
  • bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

Exclusion Criteria:

  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • History of stroke
  • Anticoagulation therapy (except of low dose aspirin <325mg)
  • Other invasive malignancy except nonmelanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Paclitaxel/Carboplatin/Bevacizumab
Drug: Carboplatin
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
Drug: Bevacizumab
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
Other Names:
  • Avastin
Drug: Paclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
Other Names:
  • Taxol
  • Taxoprol
  • Paxene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Tumor Progression
Time Frame: 1-year
1-year
Overall Survival
Time Frame: 1 year
1 year
Toxicity profile
Time Frame: Toxicity assessment of each chemotherapy cycle
Toxicity assessment of each chemotherapy cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/08.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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