Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
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.
Four (4) months after surgery, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Your performance status will be recorded.
- Blood (about 1 1/2 tablespoons) will be drawn for routine tests.
- Imaging studies including chest x-ray, PET/CT, or chest and abdominal CT will be
performed to check the status of the disease.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response (CR) Rate
Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
No
Naoto Ueno, MD, PHD
Study Chair
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2008-0372
NCT01036087
November 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |