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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691379
• Other study ID #: CT/08.02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 29, 2008
• Last updated: September 21, 2016
• Start date: April 2008
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Carboplatin
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
• Bevacizumab
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
• Paclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression

Locations

Country	Name	City	State
Greece	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

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Toxicity profile		Toxicity assessment of each chemotherapy cycle	Yes
Secondary	Time to Tumor Progression		1-year	No
Secondary	Overall Survival		1 year	No