Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer

NCT02876107 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2016-0177NCI-2017-00619
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with invasive triple negative breast cancer. Drugs used in the chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping the them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

Breast Carcinoma; Breast Lump; Edema; Erythema; Estrogen Receptor Negative; HER2/Neu Negative; Inflammatory Breast Carcinoma; Invasive Breast Carcinoma; Peau d'Orange; Progesterone Receptor Negative; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete pathologic response

  Will be estimated for each treatment arm with exact 95% confidence intervals. A Chi-square test or Fisher's exact test will be used to compare the differences in complete pathologic response rate between the two treatment arms. A logistic regression model will be used to assess the differences in complete pathologic response between the two treatment arms, adjusting for other covariates as appropriate. The analysis will be based on the modified intent-to-treat population.

  At the time of surgery, assessed up to 5 years

Secondary Outcomes (3)

• Disease free survival

  Up to 5 years

• Overall survival

  Up to 5 years

• Incidence of adverse events

  Up to 5 years

Other Outcomes (4)

• Reduced nodal expression status

  Up to 5 years

• Arginine methylation status of EGFR

  Up to 5 years

• Molecular biomarkers assessed by genomic and proteomic analysis

  Up to 5 years

Study Arms (2)

Group A (panitumumab, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive panitumumab IV over 1 hour on day 1 of cycle 0 and over 30 minutes on days 1, 8, and 15 of cycles 1-4. Patients also receive paclitaxel IV over 1-3 hours on days 1, 8, and 15 of cycles 1-4, and carboplatin IV over 30 minutes on day 1 of cycles 1-4. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unexpected toxicity.

Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Panitumumab

Group B (paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as in Group A. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unexpected toxicity.

Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Group A (panitumumab, paclitaxel, carboplatin); Group B (paclitaxel, carboplatin)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Group A (panitumumab, paclitaxel, carboplatin); Group B (paclitaxel, carboplatin)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Group A (panitumumab, paclitaxel, carboplatin); Group B (paclitaxel, carboplatin)

Panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF, Monoclonal Antibody ABX-EGF, Vectibix

Group A (panitumumab, paclitaxel, carboplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histological confirmation of breast carcinoma
• Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:
• Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass
• Duration: History of such findings no more than 6 months
• Extent: Erythema occupying at least 1/3 of whole breast
• Pathology: Pathologic confirmation of invasive carcinoma
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration \< 2, and/or copy number less than 6); ER and PgR expression should be less than 10%
• Patients have left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Platelet count \>= 100 x 10\^9/L
• Hemoglobin \>= 9.0 g/dL
• Aspartate aminotransferase (AST) =\< 3.0 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) =\< 3.0 x ULN
• Alkaline phosphatase (ALP) =\< 2.5 x ULN

You may not qualify if:

• Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible
• History of radiotherapy for current breast cancer diagnosis
• History of recent malignancies \< 5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ)
• 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 computed tomography (CT) scan
• Other known 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
• Patients with a peripheral neuropathy \> grade 1
• Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina, or cerebrovascular accident (CVA) within 6 months of protocol registration
• Patients have a history of prior therapy with carboplatin
• Patients have received a cumulative dose of doxorubicin of greater than 360 mg/m\^2 or epirubicin of greater than 640 mg/m\^2
• Patients have had prior radiotherapy for primary breast carcinoma or axillary lymph nodes
• Patients have history of diagnosed interstitial lung disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Amgen: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Wang X, Zhao L, Song X, Wu X, Krishnamurthy S, Semba T, Shao S, Knafl M, Coffer LW 2nd, Alexander A, Vines A, Bopparaju S, Woodward WA, Chu R, Zhang J, Yam C, Loo LWM, Nasrazadani A, Huong LP, Woodman SE, Futreal A; Rare Tumor Initiative Team; Tripathy D, Ueno NT. Genomic and transcriptomic analyses identify distinctive features of triple-negative inflammatory breast cancer. NPJ Precis Oncol. 2024 Nov 18;8(1):265. doi: 10.1038/s41698-024-00729-0.

  PMID: 39558017 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Edema; Erythema; Inflammatory Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; Taxes; Panitumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Manifestations

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Azadeh Nasrazadani

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: October 6, 2016
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)