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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Celgene Corporation
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01036087
First received: December 17, 2009
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, 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.


Condition Intervention Phase
Breast Cancer
Drug: Panitumumab
Drug: Nab-paclitaxel
Drug: Carboplatin
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pathologic Complete Response (CR) Rate [ Time Frame: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). ] [ Designated as safety issue: No ]
    Pathologic CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PNC + FEC

PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and

FEC = 5-fluorouracil, epirubicin, and cyclophosphamide

Drug: 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.
Other Name: Vectibix
Drug: Nab-paclitaxel
100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
Other Names:
  • Paclitaxel (protein-bound)
  • Abraxene
  • ABI-007
Drug: Carboplatin
AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
Other Name: Paraplatin
Drug: 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).
Other Names:
  • 5-FU
  • Adrucil
  • Efudex
Drug: 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).
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Other Names:
  • Cytoxan
  • Neosar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Cockcroft-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.
  11. Patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,

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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036087

Contacts
Contact: Jie Willey, MSN, BSN 713-792-3965

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Naoto Ueno, MD, PHD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Amgen
Investigators
Study Chair: Naoto Ueno, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01036087     History of Changes
Other Study ID Numbers: 2008-0372, NCI-2012-00935
Study First Received: December 17, 2009
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Inflammatory Breast Cancer
IBC
Primary breast carcinoma
HER2 negative overexpression
Panitumumab
Vectibix
Nab-paclitaxel
Paclitaxel
Abraxane
Carboplatin
Paraplatin
PNC
5-fluorouracil
5-FU
Adrucil
Efudex
Epirubicin
Ellence
Cyclophosphamide
Cytoxan
Neosar
FEC

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
Carboplatin
Paclitaxel
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 14, 2014