New hope for aggressive breast cancer: targeted combo before surgery
NCT ID NCT02876107
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug panitumumab to standard chemotherapy helps shrink tumors more effectively in people with a rare and aggressive type of breast cancer called triple-negative inflammatory breast cancer. About 42 participants will receive chemotherapy before surgery, with or without panitumumab, to see which approach leads to better outcomes. The goal is to reduce tumor size and limit the amount of breast tissue that needs to be removed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Oct 2016
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Total bilirubin =\< 1.5 x ULN * Creatinine (Cr) =\< 1.5 mg/dL x ULN * Creatinine clearance (CrCl) \>= 50 mL/min calculated by the Cockroft-Gault * Patients have the ability and willingness to sign written informed consent * Patients of childbearing potential (women who are postmenopausal for \< 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject's entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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