MDACC Study Summary 2008-0372

Study Summary
No. 2008-0372:.......Breast......Naoto Ueno......Breast Medical Oncology

Study Summary Title



Study Summary Number:	2008-0372

Study Title:	Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients with Primary Inflammatory Breast Cancer (IBC) without HER2 Overexpression

Physician

New Patient Referral



Name:	Naoto Ueno	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Breast Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8754 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	Abraxis Bio Amgen

Phase of Study:	Phase II	Return Visit:	Standard care based on the institutional guideline. Every one to three weeks patient will visit to receive chemotherapy over 6 to 7 months.Patients will be off study 4 months after surgery.

Treatment Agents:	Abraxane Carboplatin Panitumumab	Home Care:	Standard care based on the institutional guideline.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None.


Description/ Intervention:	The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, nab-paclitexal, 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 Objectives / Outcomes

Primary Objectives

is to determine the pathologic complete response (CR) rate in patients with primary inflammatory breast cancer (IBC) without HER2 overexpression by Panitumumab, Nab-paclitaxel, and Carboplatin (PNC) and FEC preoperative systemic chemotherapy.

Secondary Objectives

1.To determine the disease-free survival (DFS) produced by PNC regimens.

2.To determine the overall survival (OS) produced by PNC regimens.

3.To determine the disease-free survival (DFS) produced by PNC regimens among patients with triple negative breast cancer.

4.To determine the overall survival (OS) produced by PNC regimens patients with triple negative breast cancer.

5.To determine the safety and tolerability by PNC regimens.

6.To determine whether pathologic response rate correlates with EGFR expression level.

Exploratory

1.To identify molecular markers predictive of pathologic CR rate by analysis of multilayer immunohistochemical staining (IHC).

2.To identify molecular marker by gene profiling and proteinomics.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/01/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.

2) Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).

3) >/= Age 18

4) ECOG performance status </= 1

5) Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL

6) Adequate cardiac function (LVEF >/= 45%)

7) Adequate Renal function: Creatinine (Cr) </= 1.5 mg/dL x ULN, Creatinine clearance (CrCl) >/= 50 mL/min calculated by the Cockroft-Gault method as follows: Male creatinine clearance = (140 - age) x (weight in Kg) / (serum Cr x 72) Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)

8) Adequate Hepatic function: Aspartate aminotransferase (AST) </= 2.5 x ULN • Alanine aminotransferase (ALT) </= 2.5 x ULN • Alkaline phosphatase (Alp) </= 2.5 x ULN.Total bilirubin </=1.5 x ULN

9) Ability and willingness to sign an informed consent form for this protocol

10) If female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.

Exclusion Criteria:

1) History of radiation or chemotherapy

2) HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)

3) History or current diagnosis of metastatic or recurrent breast cancer

4) History of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)

5) Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection

6) History of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest CT scan

7) Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.

8) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

9) Peripheral neuropathy >= Gr II

Links

Registration Number: NCT01036087
Study Information on Clinical Trials Registry (clinicaltrials.gov)