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Alkylating agents

Chemotherapy +/− Panitumumab for Triple Negative Breast Cancer

Phase 2

Waitlist Available

Led By Azadeh Nasrazadani

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)

Must not have

Uncontrolled intercurrent illness including 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

Other known significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I do not have any major health or mental conditions that could affect the study's results.

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My breast cancer is at stage IV and cannot be treated with surgery.

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I have a history of severe lung disease.

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I have been diagnosed with interstitial lung disease.

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I have had radiation therapy for breast cancer or cancer in the underarm lymph nodes.

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I have mild to no nerve damage in my hands or feet.

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I have been treated with carboplatin before.

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I have received more than the maximum safe dose of doxorubicin or epirubicin.

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I have had radiotherapy for my current breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete pathologic response

Secondary study objectives

Disease free survival

Incidence of adverse events

Overall survival

Other study objectives

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 more

Side effects data

From 2009 Phase 3 trial • 463 Patients • NCT00113763

66%

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

SKIN EXFOLIATION

ABDOMINAL PAIN UPPER

INSOMNIA

COLORECTAL CANCER

STOMATITIS

SKIN ULCER

GENERAL PHYSICAL HEALTH DETERIORATION

GROWTH OF EYELASHES

MUCOSAL INFLAMMATION

JAUNDICE

ANXIETY

HEPATOMEGALY

WEIGHT DECREASED

INTESTINAL OBSTRUCTION

ANAEMIA

ASCITES

HEPATIC FAILURE

DEHYDRATION

COMA

GASTROINTESTINAL OBSTRUCTION

RECTAL HAEMORRHAGE

HYPERBILIRUBINAEMIA

CACHEXIA

METASTASES TO LIVER

METASTASES TO LUNG

HEMIPARESIS

EPILEPSY

DEPRESSED LEVEL OF CONSCIOUSNESS

HEPATIC ENCEPHALOPATHY

PULMONARY EMBOLISM

DEEP VEIN THROMBOSIS

JUGULAR VEIN THROMBOSIS

100%

80%

60%

40%

20%

Study treatment Arm

Panitumumab Plus BSC

BSC Alone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Panitumumab

2017

Completed Phase 3

~7150

Carboplatin

2014

Completed Phase 3

~6120