Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
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: April 19, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Paclitaxel
Carboplatin
Epirubicin hydrochloride
Epirubicin
Panitumumab
U.S. FDA Resources
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 ]
| 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:
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:
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.
- Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
- >/= Age 18
- ECOG performance status </= 1
- Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL
- Adequate cardiac function (LVEF >/= 45%)
- 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)
- 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
- Ability and willingness to sign an informed consent form for this protocol
- 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:
- History of radiation or chemotherapy
- HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
- History or current diagnosis of metastatic or recurrent breast cancer
- 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)
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
- 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
- Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
- 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.
- Peripheral neuropathy >= Gr II
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036087
Contacts
| Contact: Jie Willey, MSN, BSN | 713-792-3965 |
Locations
| United States, Texas | |
| UT 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 |
| Study First Received: | December 17, 2009 |
| Last Updated: | April 19, 2013 |
| 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 Antimetabolites Antimetabolites, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013