Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

NCT00618657 | Completed Phase 2 Results DMC

• 4 other identifiers: 20076084UCI 07-61NCI-2010-00155R01CA127927
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in treating patients with stage I-III breast cancer. 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 and trastuzumab, 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 tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

Breast Cancer; HER2-negative Breast Cancer; HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Keywords

pre-operative; neo-adjuvant; triple negative; HER2 positive; hormone receptor positive; breast; Carboplatin; Nab-paclitaxel; Trastuzumab; Bevacizumab; Inflammatory

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression is defined as a new lesion or a greater than or equal to 25% increase in the product of the largest perpendicular diameters of any one lesion on clinical exam or by ultrasound (U/S) or MRI. Analyzed using the Kaplan-Meier method. Cox proportional-hazards analysis will be used to derive the hazard ratio and 95% confidence interval between the two treatment arms, adjusted for clinical and demographic variables.

  2 years

Secondary Outcomes (3)

• Clinical Complete Response in the Neoadjuvant Setting

  Up to 5 years

• Number of Participants With no Evidence of Microscopic pCR in the Neoadjuvant Setting

  Up to 5 years

• Number of Participants With Toxicity of the Combinations in HER2 Positive and HER2 Negative Breast Cancer Assessed Using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0

  Up to 5 years

Study Arms (2)

Arm I (HER-2 positive)

EXPERIMENTAL

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, carboplatin IV over 60 minutes, and trastuzumab IV over 90 minutes , then weekly over 30-60 minutes. Treatment repeats every week for 12 weeks in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery.

Drug: Carboplatin; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: trastuzumab; Procedure: magnetic resonance imaging; Procedure: therapeutic conventional surgery

Arm II (HER-2 negative)

EXPERIMENTAL

Patients receive paclitaxel albumin-stabilized nanoparticle formulation and carboplatin as in Arm I. Patients also receive bevacizumab IV over 90 or 60 or 30 minutes once every two weeks for 5 doses in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery.

Drug: Carboplatin; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: bevacizumab; Procedure: magnetic resonance imaging; Procedure: therapeutic conventional surgery

Interventions

Carboplatin DRUG

Given IV

Also known as: Carboplatin Hexal, Carboplatino, CBDCA

Arm I (HER-2 positive); Arm II (HER-2 negative)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Given IV

Also known as: Albumin-Stabilized Nanoparticle Paclitaxel, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel, Nanoparticle Paclitaxel

Arm I (HER-2 positive); Arm II (HER-2 negative)

bevacizumab DRUG

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, anti-VEGF rhuMAb, recombinant humanized anti-VEGF monoclonal antibody, rhuMAb VEGF

Arm II (HER-2 negative)

trastuzumab DRUG

Given IV

Also known as: anti-c-erB-2, MOAB HER2, monoclonal antibody c-erb-2, monoclonal antibody HER2, rhuMAb HER2

Arm I (HER-2 positive)

magnetic resonance imaging PROCEDURE

Optional correlative studies

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Arm I (HER-2 positive); Arm II (HER-2 negative)

therapeutic conventional surgery PROCEDURE

Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts

Arm I (HER-2 positive); Arm II (HER-2 negative)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 1 cm and or lymph node positive * Physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration * Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible * Serum creatinine within normal limits within 90 days prior to registration * Bilirubin within normal limits within 90 days prior to registration * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2 x the institutional upper limit of normal within 90 days prior to registration * Absolute neutrophil count (ANC) of \>= 1,500/microliters within 90 days prior to registration * Platelet count of \>= 100,000/microliters within 90 days prior to registration * Patients must have a performance status of 0-2 by Zubrod criteria * Pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential * In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Taxes; 130-nm albumin-bound paclitaxel; Bevacizumab; Trastuzumab; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: UC Irvine Health / Chao Family Comprehensive Cancer Center
• Organization: UC Irvine Health / Chao Family Comprehensive Cancer Center

ucstudy@uci.edu

1-877-UC-STUDY

Study Officials

• Rita Mehta, M.D.

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Clinical Professor

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 28, 2024
• Results First Posted: October 4, 2023

Record last verified: 2024-02

Locations

US (1)