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A Phase II Study of Using Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen (AC) for New Triple-Negative Inflammatory Breast Cancer (TN-IBC)

2016-08-24 12:53:21 | BioPortfolio

Summary

The goal of this clinical research study is to learn if adding panitumumab to the combination of carboplatin and paclitaxel can help to control IBC when given before other standard chemotherapy and surgery. The safety of these drug combinations will also be studied.

Description

Study Groups:

If participant is found to be eligible to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. Participant will have an equal (50/50) chance of being assigned to either group, and participant and the study staff will know what participant is receiving:

- If participant is in Group A, they will receive panitumumab, carboplatin, and paclitaxel, followed by doxorubicin and cyclophosphamide.

- If participant is in Group B, they will receive carboplatin and paclitaxel, followed by doxorubicin and cyclophosphamide.

Study Drug Administration:

Every study cycle will be 21 days.

Participant will receive paclitaxel by vein over about 1-3 hours on Days 1, 8, and 15 of Cycles 1-4.

Participant will receive carboplatin by vein over about 30 minutes on Day 1 of Cycles 1-4.

If participant is in Group A, they will also receive panitumumab by vein. Participant will first receive it over about 1 hour on Day 1 of a 1-week "pre-cycle." Participant will then receive it over about 30 minutes on Days 1, 8, and 15 of Cycles 1-4, before they receive paclitaxel.

Participant will then receive standard of care doxorubicin and cyclophosphamide by vein over about 90 minutes on Day 1 of Cycles 5-8.

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

Study Visits:

For both Groups A and B:

- Every day that participant receives the study drugs, and then at any time before surgery and after the last dose of doxorubicin and cyclophosphamide, blood (about 1½ to 3 tablespoons) will be drawn for routine tests.

- Before each cycle, and then at any time before surgery and after the last dose of doxorubicin and cyclophosphamide, participant will have a physical exam including a breast and lymph node exam.

- On Day 1 of Cycle 1, then 1 time before participant begins receiving doxorubicin and cyclophosphamide, and then 1 time before surgery, the study doctor will take pictures of both of participant's breasts.

- Before receiving any treatment, on Day 1 of Cycle 1, then 1 time before participant begins receiving doxorubicin and cyclophosphamide, and then 1 time before surgery , blood (about 5 tablespoons) will be drawn for cytokine testing.

- One (1) time before participant begins receiving doxorubicin and cyclophosphamide , they will have a mammogram of the involved breast and an ultrasound of the involved breast and lymph nodes. Participant may have a breast MRI if the doctor thinks it is needed.

If participant is in Group A, they will have a breast core biopsy before Day 1 of Cycle 1 for biomarker testing.

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

Surgery:

After participant has finished receiving doxorubicin and cyclophosphamide, they will have standard of care surgery. Participant will be given a separate consent form to read and sign.

During surgery, breast tissue samples will be collected to identify tumors for routine testing and for biomarker testing.

Length of Study:

Participant may continue taking the study drugs for up to 8 cycles. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

Patient's participation on the study will be over after the follow-up period.

Follow-Up:

About 1 month after surgery, participant will be asked about their health and any side effects they may have had. Participant may be asked during a routine clinic visit or they may be called by a member of the study staff. If participant is called, each call should last about 2 minutes.

One (1) time every year for at least 5 years after participant stops taking the study drugs, they will be contacted and asked about how they are doing. If participant is called, each call should last about 2 minutes. This may also be done in a regular clinic visit.

This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer with disease progression. Paclitaxel, carboplatin, doxorubicin and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. The addition of panitumumab to the combination of carboplatin and paclitaxel is investigational and currently being used for research purposes only. The study doctor can describe how the study drugs are designed to work.

Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Neoplasm of Breast

Intervention

Breast Core Biopsy, Paclitaxel, Carboplatin, Panitumumab, Doxorubicin, Cyclophosphamide, Mammogram, Ultrasound, Follow Up

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-24T12:53:21-0400

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

The use of needles usually larger than 14-gauge to remove tissue samples large enough to retain cellular architecture for pathology examination.

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

Conducting a biopsy procedure with the aid of a MEDICAL IMAGING modality.

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