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Alkylating agents

Chemotherapy +/− Trastuzumab for Breast Cancer

Phase 2

Waitlist Available

Led By Amulya Yellala

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with histologically proven invasive breast cancer without distant metastases; a clinical tumor size of at least 1 cm with or without evidence of positive nodes

Patient's awareness of the neoplastic nature of the disease and provision of written, informed consent

Must not have

Uncontrolled inter-current illness

Prior malignancy except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing paclitaxel and cyclophosphamide with or without trastuzumab before surgery to see if it can reduce the amount of normal tissue that needs to be removed in patients with previously untreated breast cancer.

Who is the study for?

This trial is for women with invasive breast cancer without distant metastases, a tumor size of at least 1 cm, and no severe illnesses that would prevent consent. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and can't have had certain prior treatments or other cancers.

What is being tested?

The study tests how well paclitaxel and cyclophosphamide chemotherapy work with or without trastuzumab (a monoclonal antibody) before surgery in patients with untreated breast cancer. The goal is to shrink the tumor and limit surgery to remove less tissue.

What are the potential side effects?

Possible side effects include reactions from the infusion of drugs like trastuzumab, blood cell count changes due to chemotherapy agents such as paclitaxel and cyclophosphamide, fatigue, nausea, risk of infection increase, heart problems related to trastuzumab therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with breast cancer that has not spread far and my tumor is at least 1 cm big.

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I understand my cancer diagnosis and have given written consent for treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My heart pumps well and has normal movement.

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 unmanaged ongoing illnesses.

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I have had cancer before, but it was either skin cancer treated successfully or a non-spreading type that was treated.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I cannot have surgery.

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I am unable to follow the treatment plan as required.

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I have HIV, hepatitis, or liver problems.

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My breast cancer is inflammatory, stage IV, or has spread to other parts.

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I have moderate numbness, pain, or tingling in my hands or feet.

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I have had chemotherapy or hormone therapy for breast cancer or another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR)

Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0

Secondary study objectives

Clinical Complete Response

Failure-free Survival (FFS)

Identification of Gene Expression Profile Signatures That Correlate With Clinical Response as Measured by pCR

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