Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
University Hospital of Crete
Information provided by (Responsible Party):
VASSILIKI SXOINA, Hellenic Oncology Research Group Identifier:
First received: May 29, 2008
Last updated: September 21, 2016
Last verified: September 2016
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

Condition Intervention Phase
Breast Cancer
Drug: Carboplatin
Drug: Bevacizumab
Drug: Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 Name: Avastin
Drug: Paclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
Other Names:
  • Taxoprol
  • Paxene
  • Taxol

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00691379

University General Hospital of Alexandroupolis
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
University Hospital of Crete
Heraklion, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Diabalkaniko" hospital, Thessaloniki
Thessaloniki, Greece
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

Responsible Party: VASSILIKI SXOINA, Prof. D. Mavroudis, Hellenic Oncology Research Group Identifier: NCT00691379     History of Changes
Other Study ID Numbers: CT/08.02 
Study First Received: May 29, 2008
Last Updated: September 21, 2016
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Breast cancer
Triple negative
Anti-angiogenesis therapy

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on October 21, 2016