Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Breast Carcinoma In Situ

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 3 weeks.

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 4 weeks

Weekly oral dose of 50,000 IU Vitamin D3 (VD) for 5 weeks.

Weekly oral dose of 50,000 IU Vitamin D3 (VD) therapy for the duration selected from the phase I part of the study.

Weekly oral dose of Vitamin D3 per protocol.

Eli Avisar, MD

High-doses of Vitamin D (VD) may be used as targeted therapy against breast cancer. The investigators will assess the effect of high dose VD on the following biomarkers in the breast cancer cells: VDR, estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2/neu), androgen receptor (AR), as well as epidermal growth factor receptor 1 (EGFR) and Ki-67, as markers of proliferation, and E-cadherin, a marker of invasion and metastasis.

This is a phase I/II open-label, non-randomized study. In phase I, a fixed weekly course of oral high-dose Vitamin D (VD) is planned for either 3, 4 or 5 weeks; patients will be sequentially enrolled into 3 groups (A, B or C respectively) in a manner such that no more than two patients may have treatment-limiting toxicities (TLTs).

After the group with the optimal duration of VD therapy to achieve a "favorable response" is determined, phase II will begin enrollment.

Patients must be scheduled to have surgery performed within 2- weeks of the last dose of VD.

Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors

Phase I/II Study Evaluating Safety and Effects of Preoperative High-Dose Vitamin D on the Receptors, Biomarkers and Pathological Characteristics of High Grade DCIS or Invasive Breast Cancer.

Rate of treatment-related adverse events and other toxicities in subjects.

Rate of subjects achieving a "favorable treatment response" to protocol therapy given within the optimal duration determined in Phase 1. The effect of VD therapy will be assessed in terms of change in expression of VDR, ER, PR, HER2/neu, AR, Ki-67, E-cadherin and EGFR comparing surgical specimen (post-VD treatment) and baseline biopsy specimen (pre-VD treatment). The effect of VD will be described as increased expression, decreased expression or no change in expression of each marker/receptor measured.

The expression of nuclear receptors/proteins (VDR, Ki-67, ER, PR, AR,) will be scored based on the percentage of positively staining nuclei as follows:

* 0 (Negative) if \<1%
* +1 (Weak) if \>1-10%
* +2 (Moderate) if \>10-50%
* +3 (Strong) if \>50%

A decrease in the expression of Ki-67 by ≥+1 after treatment is considered a "favorable treatment response".

The determination of the optimal duration of once-weekly protocol therapy, 3, 4 or 5 weeks, as preoperative treatment to achieve a "favorable" treatment response in subjects with the study disease. The effect of VD therapy will be assessed in terms of change in expression of VDR, ER, PR, HER2/neu, AR, Ki-67, E-cadherin and EGFR comparing surgical specimen (post-VD treatment) and baseline biopsy specimen (pre-VD treatment). The effect of VD will be described as increased expression, decreased expression or no change in expression of each marker/receptor measured.

The expression of nuclear receptors/proteins (VDR, Ki-67, ER, PR, AR,) will be scored based on the percentage of positively staining nuclei as follows:

* 0 (Negative) if \<1%
* +1 (Weak) if \>1-10%
* +2 (Moderate) if \>10-50%
* +3 (Strong) if \>50%

A decrease in the expression of Ki-67 by ≥+1 after treatment is considered a "favorable treatment response".

Eli Avisar

Professor

Rare Diseases

Inflammatory Breast Neoplasms

Inflammatory Breast Cancer

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Fluorouracil

Cyclophosphamide

Epirubicin

Lapatinib

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.

Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.

1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m\^2, Epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).

1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.

80 mg/m\^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.

500 mg/m\^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.

5-Fluorouracil (5-FU)

75 mg/m\^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.

500 mg/m\^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.

Ricardo Alvarez, MD

The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer (IBC). The safety of this drug combination will also be studied.

The Study Drugs:

Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor and the epidermal growth factor (EGFR).

Cyclophosphamide, paclitaxel, and 5-fluorouracil are designed to block cancer cells from dividing, which may slow or stop their growth and their ability to spread throughout the body. This may cause the cancer cells to die.

Epirubicin is designed to attach to DNA (the genetic material of cells) which may slow or stop their growth and cause them to die.

Study Drug Administration:

On Weeks 1-24 you will take lapatinib every day by mouth with water (about 8 ounces). It should be taken at least 1 hour before or at least 2 hours after eating. It is important that you take the study drug at about the same time every day. You should not eat pamelo fruit, grapefruit, star fruit, pawpaw, and/or drink their juices while on study.

If you forget to take a dose of the study drug, you should take the missed dose as soon as you remember, unless it has been more than 12 hours. If it has been more than 12 hours, do not take the missed dose. Instead, take the next dose as scheduled the next day. If you vomit after taking the study drug, wait until the next day to take your next dose.

The study drug should be stored at room temperature and out of direct sunlight. The study drug should be kept away from children. About every 3 weeks, you will need to bring back your empty or partially used bottle of study drug as instructed by your doctor.

On Weeks 3-12, you will receive paclitaxel through a needle in your vein 1 time a week. The infusion will take about 1 hour. You will continue to take lapatinib every day.

On Weeks 13-24, you will receive 5-fluorouracil, epirubicin, and cyclophosphamide 1 time every 21 day study cycle. You will receive 4 cycles. Each 5-fluorouracil infusion will take about 3-5 minutes, each epirubicin infusion will take about 5-10 minutes, and the cyclophosphamide infusion will take about 45-60 minutes. You will continue to take lapatinib every day during Weeks 13-24.

If you experience intolerable side effects, the study doctor may give you drugs to help with this side effect or change your dose of study drug.

Study Visits:

On Day 1 of Week 1, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any drugs that you may be taking.
* You will have a performance status evaluation.

Every 3 weeks while taking combination chemotherapy and study drug, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any changes in your health and any drugs that you may be taking.
* You will have a performance status evaluation.
* Your medical history will be recorded.
* Blood (about 3 tablespoons) will be drawn for routine tests.

At Week 6, you will have a CT scan, MRI, and/or a bone scan to check the status of the disease.

At the end of the chemotherapy treatment, the disease will be measured by physical exam, chest CT scan and sonogram to check the status of the disease. If the disease has gotten worse, you will be taken off study. If the disease has gotten worse, you will be taken off study. Your doctor will discuss your next step of treatment options.

Surgery:

At the end of the chemotherapy period, if the disease has responded well to the drugs, you will have surgery to remove the breast tumor. You will sign a separate consent form for the surgery. Either at the end-of-treatment visit at week 24 after you are done with chemotherapy, or before the surgery, the following tests will be performed:

* You will have a complete physical exam, including measurement of your vital signs and weight.
* You will have a performance status evaluation.
* You will be asked about any drugs you may be taking.
* Blood (about 3 tablespoons) will be drawn for routine tests
* You will have an ECG.
* You will have a multiple gated acquisition scan (MUGA) or echocardiogram to check your hearts health.
* You will have a CT scan, MRI, and/or a bone scan to check the status of the disease.
* You will have a tissue biopsy to check the status of the disease.

Length of Study:

You may continue to receive the study drugs for up to 24 weeks. You will be taken off study early if the disease gets worse or intolerable side effects occur.

Long-Term Follow-Up:

Once you are off study, you will have follow-up visits at 3 and 6 months after surgery. At these visits, you will have a MUGA or ECHO performed.

You will have additional visits every 4 months for Years 2 and 3, and then every 6 months for Years 4 and 5. At these visits, blood (about 3 tablespoons) will be drawn for routine tests.

This is an investigational study. Lapatinib is FDA approved and commercially available when taken in combination with capecitabine for another type of breast cancer. Using Lapatinib in inflammatory breast cancer is investigational.

5-fluorouracil, epirubicin, cyclophosphamide, and paclitaxel are all FDA approved and commercially available for treating breast cancer. The combination of these drugs is not currently FDA approved for the treatment of IBC. At this time, this drug combination is only being used in research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Phase II Neoadjuvant in Inflammatory Breast Cancer

A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu)

Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.

Pathologic complete response \[pCR or RCB Class 0\] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.

GlaxoSmithKline

M.D. Anderson Cancer Center

Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.

Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.

1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).

Neoadjuvant Lapatinib Plus Chemotherapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

PS 0

PS 1

Eastern Cooperative Oncology Group (ECOG) performance status (PS) performed at baseline. PS described as 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; etc.

ECOG (Performance Status)

III B

III C

AJCC Breast cancer staging: Anatomic stage 0, IA or B, IIA or B, IIIA to C or IV. AJCC staging system provides strategy for grouping participants by prognosis, based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined , and an overall stage of 0, I, II, III, IV is assigned from least advanced to more advanced. Sometimes these stages are subdivided as well, using letters such as IIIA and IIIB.

Clinical Stage: American Joint Committee on Cancer (AJCC) 2009

Ricardo Alvarez, MD/Breast Medical Oncology

RCB Class 0 (pCR)

RCB Class I

RCB Class II

RCB Class III

While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.

Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)

With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.

Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.

Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.

1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.
2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).

Overall Study

Bevacizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Suparna Wedam, M.D.

This study will evaluate the effectiveness of the drug bevacizumab, in combination with doxorubicin and docetaxel, in improving survival of patients with inflammatory breast cancer or locally advanced breast cancer. Inflammatory breast cancer is an aggressive form of locally advanced breast cancer that often causes a red, swollen, tender breast and is associated with a poor prognosis. Bevacizumab blocks the growth of new blood vessels that supply oxygen and nutrients to tumors, and therefore, may kill cancer cells or stop their growth. Doxorubicin and docetaxel are approved drugs for treating breast cancer.

Patients 18 years of age or older with stage inflammatory breast cancer who have not been treated with chemotherapy or radiation therapy may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, chest x-ray, electrocardiogram, and MUGA scan or echocardiography (see below). A mammogram of both breasts, dynamic MRI imaging of the affected breast, computed tomography (CT) of the head, chest, abdomen and pelvis, and a bone scan are done to determine the extent of disease.

Participants undergo the following procedures at various intervals before, during and/or after completing chemotherapy:

Tumor and skin biopsies to study the effects of bevacizumab on tumor blood vessels, tumor growth, and the biology of inflammatory breast cancer. A small piece of tumor tissue and a small piece of skin from the affected breast are removed under local anesthesia for microscopic study.

Dynamic MRI to examine changes in the blood vessels and breast cancer following bevacizumab treatment. This test involves injecting a contrast liquid into a vein before scanning. A standard MRI scan is done before the dynamic MRI.

Blood tests are done to 1) study clot formation and breakdown, 2) measure levels of VEGF (a substance produced by breast cancer cells) and VCAM-1 (a substance produced by cells lining blood vessel walls), and 3) check blood counts and liver and kidney function.

MUGA (a nuclear medicine scan that checks the heart's pumping ability) or echocardiogram (ultrasound scan of the heart to evaluate heart function.

Blood pressure monitoring

Urine tests

CT scans and x-rays to evaluate disease before and after treatment.

Patients will have a central venous line (plastic tube) placed into a major vein in the chest before beginning treatment. The line stays in the body during the entire treatment period and is used to give chemotherapy and other medications, if needed, and to draw blood samples. All treatment is given on a single day every 3 weeks. This constitutes one treatment cycle. Cycle 1 consists of bevacizumab alone; cycles 2 through 7 consist of bevacizumab with doxorubicin and docetaxel. During each cycle, patients also receive injections under the skin of G-CSF, a drug that raises the number of infection-fighting white blood cells, which are often decreased as a side effect of chemotherapy. After cycle 7, patients may require surgery and radiation or radiation alone. After radiation treatment, bevacizumab is re-started, given alone every 3 weeks for an additional eight cycles. Patients whose tumors are positive for estrogen or progesterone receptors will be advised to take the drug tamoxifen or anastrozole for 5 years to decrease the chances of disease recurrence. This would begin with cycle 8.

This is a pilot study in patients with previously untreated inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC) to evaluate angiogenesis parameters after treatment with rhuMAb VEGF - recombinant humanized monoclonal antibody vascular endothelial growth factor (bevacizumab). The challenge for new molecular-targeted anti-angiogenesis therapy is to devise appropriate and reliable markers to monitor efficacy. This may be achieved directly by evaluating changes in angiogenesis parameters in tumor samples. The use of less invasive surrogate markers to assess the efficacy of anti-angiogenic therapy is preferable. This may include functional changes in tumor vasculature assessed using non-invasive methods such as magnetic resonance imaging (MRI) or determination of changes in circulating soluble markers of angiogenesis.

Most breast cancers over express VEGF thus making it an ideal disease for treatment with anti-angiogenesis therapy. This study will evaluate the effects of bevacizumab on angiogenesis parameters both molecular and functional. The first cycle will consist of bevacizumab alone followed by six cycles of bevacizumab in combination with doxorubicin and docetaxel (AT). Loco-regional therapy will follow and bevacizumab will be recommenced for eight cycles.

Changes in pre-designated angiogenesis parameters will be assessed at baseline, three weeks after bevacizumab and after three cycles of AT/bevacizumab. The first three molecular parameters: endothelial cell proliferation, endothelial cell apoptosis and tissue VEGF require multiple tumor core biopsies obtained using a mammotome. The fourth parameter k(ep), the redistribution constant is obtained using dynamic MRI. To determine the variability of the values of the three molecular primary angiogenesis parameters, multiple biopsies will be sampled at the same time points. An attempt will be made to correlate each of the four primary angiogenesis parameters with time to progression/recurrence. The effects of bevacizumab alone and AT/bevacizumab directly on tumor vasculature using dynamic MRI imaging and on the circulating angiogenesis marker, serum vascular cell adhesion molecule-1 (VCAM-1) at the same three time points and prior to surgery and will be undertaken in an exploratory manner. An attempt will be made to correlate changes in these parameters with clinical findings and changes in tissue angiogenesis parameters. Additionally, other angiogenesis biomarkers will also be studied in an exploratory manner.

Thrombosis factors will be monitored given the increased incidence of venous and arterial thrombosis seen in previous clinical trials using bevacizumab. An increase in the incidence of hypertension has also been seen. A subset of patients in this study will undergo frequent blood pressure monitoring to obtain a profile of the effect of bevacizumab on blood pressure.

Bevacizumab to Treat Inflammatory Breast Cancer or Locally Advanced Breast Cancer

A Pilot Study to Evaluate Angiogenesis After Treatment With Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) in Previously Untreated Patients With Inflammatory Breast Cancer or Locally Advanced Breast Cancer

National Cancer Institute (NCI)

Suparna B. Wedam, M.D./National Cancer Institute

Carboplatin

Panitumumab

PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and

FEC = 5-fluorouracil, epirubicin, and cyclophosphamide

2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.

100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.

Nab-paclitaxel

AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.

500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

5-Fluorouracil

100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Naoto Ueno, MD, PHD

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.

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.

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

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

Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.

AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (\>/=2 non-hematological and \>/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section.

Celgene Corporation

Amgen

PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and

FEC = 5-fluorouracil, epirubicin, and cyclophosphamide

Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.

Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.

Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.

5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

PNC + FEC

Menopausal Status

N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.

Clinical N Category

Clinical Stage for inflammatory breast cancer was determined by the presence of distant metastases at initial diagnosis. Stage III was confined to the regional area and stage IV had distant metastases. Stage IV was considered worse outcomes.

Clinical TNM Stage at Presentation

Grade 2

Grade 3

A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. A high grade number (grade 3) means a faster-growing cancer that's more likely to spread. An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors	NCT02856503	Breast Cancer Invasive Breast... Ductal Carcinom...	Vitamin D3	18 Years -	University of Miami
Phase II Neoadjuvant in Inflammatory Breast Cancer	NCT00756470	Breast Cancer	Lapatinib Paclitaxel 5-Fluorouracil ... Epirubicin Cyclophosphamid...	18 Years -	M.D. Anderson Cancer Center
Bevacizumab to Treat Inflammatory Breast Cancer or Locally Advanced Breast Cancer	NCT00016549	Breast Cancer	Bevacizumab	18 Years -	National Institutes of Health Clinical Center (CC)
Bevacizumab to Treat Inflammatory Breast Cancer or Locally Advanced Breast Cancer	NCT00016549	Breast Cancer	Bevacizumab	18 Years -	National Institutes of Health Clinical Center (CC)
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer	NCT01036087	Breast Cancer	Panitumumab Nab-paclitaxel Carboplatin 5-Fluorouracil Epirubicin Cyclophosphamid...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ibc

Every month we try and update this database with for ibc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibc

Every month we try and update this database with for ibc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.