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Alkylating agents
Chemotherapy +/− Panitumumab for Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Naoto Ueno
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histological confirmation of breast carcinoma
Patients must have negative HER2 expression on immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying carboplatin and paclitaxel with or without panitumumab to see how well they work in treating triple negative breast cancer.
Who is the study for?
This trial is for patients with invasive triple negative breast cancer who haven't had certain treatments like carboplatin or radiotherapy for their condition. They should have good organ function, no serious heart issues, and not be dealing with other major medical or psychiatric conditions that could affect the study. Women of childbearing age must test negative for pregnancy and agree to use birth control.Check my eligibility
What is being tested?
The trial is testing how well a combination of chemotherapy drugs (carboplatin and paclitaxel) works when given alone versus when combined with panitumumab, a monoclonal antibody. The goal is to see if adding panitumumab can better shrink tumors before surgery in patients with this type of breast cancer.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, nerve damage (neuropathy), blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme changes, kidney function alterations, fatigue, hair loss from chemotherapy and potential heart damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has been confirmed by a tissue examination.
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My cancer does not show HER2 activity based on specific tests.
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My heart pumps well, with an ejection fraction of 50% or higher.
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My breast cancer diagnosis is confirmed by international standards.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete pathologic response
Secondary outcome measures
Disease free survival
Incidence of adverse events
Overall survival
Other outcome measures
Arginine methylation status of EGFR
Downregulation of COX-2 pathway and mesenchymal marker by EGFR pathway
Molecular biomarkers assessed by genomic and proteomic analysis
+1 moreSide effects data
From 2009 Phase 3 trial • 463 Patients • NCT0011376366%
ERYTHEMA
58%
PRURITUS
57%
DERMATITIS ACNEIFORM
28%
ANOREXIA
26%
FATIGUE
25%
PARONYCHIA
24%
ABDOMINAL PAIN
22%
RASH
22%
NAUSEA
21%
DIARRHOEA
20%
SKIN FISSURES
19%
CONSTIPATION
18%
EXFOLIATIVE RASH
18%
VOMITING
16%
PYREXIA
16%
DYSPNOEA
15%
COUGH
14%
ACNE
13%
COLORECTAL CANCER METASTATIC
12%
OEDEMA PERIPHERAL
12%
ASTHENIA
10%
BACK PAIN
10%
NAIL DISORDER
10%
DRY SKIN
9%
SKIN EXFOLIATION
8%
ABDOMINAL PAIN UPPER
7%
INSOMNIA
7%
COLORECTAL CANCER
7%
STOMATITIS
6%
SKIN ULCER
6%
GENERAL PHYSICAL HEALTH DETERIORATION
6%
GROWTH OF EYELASHES
6%
MUCOSAL INFLAMMATION
6%
JAUNDICE
6%
ANXIETY
5%
HEPATOMEGALY
5%
WEIGHT DECREASED
5%
INTESTINAL OBSTRUCTION
5%
ANAEMIA
2%
ASCITES
2%
HEPATIC FAILURE
2%
DEHYDRATION
1%
COMA
1%
GASTROINTESTINAL OBSTRUCTION
1%
RECTAL HAEMORRHAGE
1%
HYPERBILIRUBINAEMIA
1%
CACHEXIA
1%
METASTASES TO LIVER
1%
METASTASES TO LUNG
1%
HEMIPARESIS
1%
EPILEPSY
1%
DEPRESSED LEVEL OF CONSCIOUSNESS
1%
HEPATIC ENCEPHALOPATHY
1%
PULMONARY EMBOLISM
1%
DEEP VEIN THROMBOSIS
1%
JUGULAR VEIN THROMBOSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panitumumab Plus BSC
BSC Alone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B (paclitaxel, carboplatin)Experimental Treatment3 Interventions
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.
Group II: Group A (panitumumab, paclitaxel, carboplatin)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Panitumumab
2020
Completed Phase 3
~6490
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,760 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,625 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Naoto UenoPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had any cancer except for skin cancer or cervical cancer in the last 5 years.You have tested positive for HIV, hepatitis C, or have active hepatitis B infection.I do not have any major health or mental conditions that could affect the study's results.My breast cancer is at stage IV and cannot be treated with surgery.I have a history of severe lung disease.My breast cancer has been confirmed by a tissue examination.I have been diagnosed with interstitial lung disease.I have had radiation therapy for breast cancer or cancer in the underarm lymph nodes.My cancer does not show HER2 activity based on specific tests.My heart pumps well, with an ejection fraction of 50% or higher.Your hemoglobin level is at least 9.0 grams per deciliter.Your alanine aminotransferase (ALT) levels are not more than 3 times the upper limit of normal.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.I have been treated with carboplatin before.My breast cancer diagnosis is confirmed by international standards.I am fully active or restricted in physically strenuous activity but can do light work.Your kidneys work well enough to filter out waste from your blood.I am willing and able to sign the consent form.I have mild to no nerve damage in my hands or feet.I have not had severe heart failure or a heart attack in the last 6 months.Your absolute neutrophil count is equal to or higher than 1.5 x 10^9/L.Your creatinine levels must be lower than 1.5 mg/dL.I have received more than the maximum safe dose of doxorubicin or epirubicin.I have had radiotherapy for my current breast cancer.Your platelet count must be at least 100 billion per liter of blood.Your alkaline phosphatase levels are not more than 2.5 times the upper limit of normal.Your AST level in the blood is not more than three times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (panitumumab, paclitaxel, carboplatin)
- Group 2: Group B (paclitaxel, carboplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What preceding experiments have included Panitumumab in their designs?
"Presently, 1204 Panitumumab clinical trials are underway, of which 335 are in Phase 3. Though Shanghai is a hub for such studies, 66990 sites across the world have participated in these experiments."
Answered by AI
What maladies does Panitumumab generally seek to address?
"Panitumumab may be used to treat advanced endometrial cancer but can also offer relief from melanoma, metastatic neoplasm, and fluoropyrimidine-, oxaliplatin- and irinotecan-resistant progression."
Answered by AI
How many volunteers are partaking in this experiment?
"This experiment is presently not taking on new participants. Initially posted on October 6th, 2016 and last modified July 12 2022, this medical trial has already been completed. If you're interested in joining a clinical study, there are currently 4668 edema trials and 1204 Panitumumab studies actively recruiting volunteers."
Answered by AI
Has the federal government sanctioned Panitumumab for medicinal use?
"Our evaluation of Panitumumab's safety concluded with a score of 2 as it is partway through its Phase 2 clinical trial, indicating that there are some records to support its security but none for efficacy."
Answered by AI
Are participants currently being enrolled in this research endeavor?
"At present, no new candidates are being sought for this medical trial. It was first listed in October 6th 2016 and last modified on July 12th 2022. However, there are currently 4668 clinical trials looking to recruit patients with edema and 1204 studies actively enrolling individuals who will receive Panitumumab treatment."
Answered by AI
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