Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer

Breast Cancer Clinical Trial

Official title: Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.

Clinical Trial Description

Study Drugs:

Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR).

Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor.

Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow.

5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Drug Administration:

On Day 1 of Week 1, you will receive panitumumab through a needle in your vein over 60 minutes.

After Week 1, you will receive a total of 4 cycles of PNC. Each cycle is 4 weeks.

During Cycles 1-3 (Weeks 2-13), you will receive PNC by vein once a week for 3 weeks, followed by a week of rest. You will receive PNC through a needle in your vein. The infusion will take 90 minutes.

During Cycle 4 (Week 14 to 17), you will receive PNC on Day 1 of Weeks 14 and 15. On Day 1 of Week 16, you will receive only carboplatin and nab-paclitaxel.

Starting on Day 1 of Week 18, you will receive FEC through a needle in your vein. The infusion will take 90 minutes. You will receive a total of 4 cycles, each 3 weeks long, over 12 weeks.

Surgery:

After you have completed both PNC and FEC treatments, you will have the standard of care surgery performed. You will be given a separate consent form to read and sign.

During surgery, breast tissue samples will be collected to identify tumors as routine procedure.

Study Visits:

Each week that you receive PNC or FEC therapy, before each dose of chemotherapy, blood (about 1 1/2 tablespoons) will be drawn for routine tests.

Before Week 2, an optional breast core biopsy will be performed to collect tumor samples for biomarker testing

On Week 2, every 4 weeks after that until the end of PNC, and again before FEC, the following tests and procedures will be performed before each dose of chemotherapy.

• You will have a physical exam, including measurement of your vital signs and weight, and breast exam.

• Blood (about 1 1/2 tablespoons) will be drawn for routine tests.

• You will be asked how well you are able to perform the normal activities of daily living (performance status).

During Weeks 2 and 9, and before FEC therapy, the study doctor will take pictures of both of your breasts.

Before FEC (after Cycle 4 of PNC) and again before surgery, the following tests and procedures will be performed:

• To check the status of the disease, imaging studies including mammogram, breast MRI, breast ultrasound, and digital photograph will be performed.

• You will have a physical exam, including vital signs, weight, and breast exam

• Blood (about 3 tablespoons) will be drawn for routine tests.

• You will be asked about any symptoms that you may have.

• The ECGs and ECHO/MUGA scans will be repeated, when the doctor thinks it is necessary.

This schedule may be changed if the study doctor thinks that it is necessary.

Length of the study:

You may remain on study treatment for up to 10 months. You will be taken off study early if the disease gets worse or you experience intolerable side effects.

This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. It's use in this study is considered to be investigational.

Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The use of Nab-paclitaxel in this study is considered to be investigational.

Carboplatin is FDA approved and commercially available for the treatment of IBC.

FEC is FDA approved for breast cancer in general, but not specifically for inflammatory breast cancer.

The use of PNC and FEC together before surgery is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01036087
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Completion date: August 9, 2022