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
2 other identifiers
interventional
47
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Nov 2010
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2022
CompletedResults Posted
Study results publicly available
September 21, 2022
CompletedMarch 30, 2023
March 1, 2023
5.3 years
December 17, 2009
July 14, 2022
March 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants That Achieved Pathologic Complete Response (CR)
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.
Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
Secondary Outcomes (1)
Number of Participants With Treatment-related Adverse Events (AEs)
Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.
Study Arms (1)
PNC + FEC
EXPERIMENTALPNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
Interventions
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.
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).
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).
Eligibility Criteria
You may qualify if:
- 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 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)
- 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.
- 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,
You may not qualify if:
- History of radiation or chemotherapy
- HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Celgene Corporationcollaborator
- Amgencollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Matsuda N, Wang X, Lim B, Krishnamurthy S, Alvarez RH, Willey JS, Parker CA, Song J, Shen Y, Hu J, Wu W, Li N, Babiera GV, Murray JL, Arun BK, Brewster AM, Reuben JM, Stauder MC, Barnett CM, Woodward WA, Le-Petross HTC, Lucci A, DeSnyder SM, Tripathy D, Valero V, Ueno NT. Safety and Efficacy of Panitumumab Plus Neoadjuvant Chemotherapy in Patients With Primary HER2-Negative Inflammatory Breast Cancer. JAMA Oncol. 2018 Sep 1;4(9):1207-1213. doi: 10.1001/jamaoncol.2018.1436.
PMID: 29879283DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Naoto Ueno, Professor, Breast Medical Oncology
- Organization
- UT MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
Naoto Ueno, MD, PHD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 21, 2009
Study Start
November 1, 2010
Primary Completion
February 11, 2016
Study Completion
August 9, 2022
Last Updated
March 30, 2023
Results First Posted
September 21, 2022
Record last verified: 2023-03