Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Biological: bevacizumab; Drug: Carboplatin; Drug: ABI-007

• Registration Number: NCT00654836
• Lead Sponsor: Loyola University

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

* To determine the progression-free survival of patients with locally recurrent or metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, and bevacizumab as first-line therapy.

Secondary

* To determine the response rate in these patients.

* To determine the overall survival of these patients.

* To evaluate the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and 43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30 minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.

Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by immunohistochemistry (IHC) for various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in tumor-associated endothelial cells are correlated with response in both estrogen- and progesterone-positive and negative tumors, and independently of p53 status.

After completion of study treatment, patients are followed for up to 2 years.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-09
• Primary Completion: 2012-02
• Study Completion: 2015-09
• Results First Submitted: 2016-08-19
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-16
• Last Update Submitted: 2017-08-16
• Results First Posted: 2017-09-14
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin, ABI-007 and Bevacizumab	bevacizumab	Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)
Carboplatin, ABI-007 and Bevacizumab	Carboplatin	Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)
Carboplatin, ABI-007 and Bevacizumab	ABI-007	Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	30 Months	Progression-free survival was measured from treatment initiation to 30 months. 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.

Secondary Outcome Measures

Name	Time	Method
Response Rate at End of Treatment	30 Months	Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 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 .
Overall Survival	80 Months	Overall survival was measured from treatment initiation to 80 months

Trial Locations

Locations (6)

Delnor Community Hospital - Geneva; 🇺🇸 Geneva, Illinois, United States

Swedish-American Regional Cancer Center; 🇺🇸 Rockford, Illinois, United States

Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital; 🇺🇸 Downers Grove, Illinois, United States

Edward Hospital Cancer Center; 🇺🇸 Naperville, Illinois, United States

Central Dupage Cancer Center; 🇺🇸 Winfield, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States