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Chemotherapy + Trastuzumab for Early-Stage HER2 Positive 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

All included subjects must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram

Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer

Must not have

Inability to cooperate with treatment protocol

Subjects with pre-existing grade II peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 20 Other Conditions

Summary

This trial is testing the side effects and efficacy of giving cyclophosphamide, paclitaxel, and trastuzumab after surgery to patients with early-stage HER2/neu positive breast cancer.

Who is the study for?

This trial is for women with stage I-II HER2/neu positive breast cancer post-surgery. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and have no history of severe illnesses or conditions that could interfere with the study.

What is being tested?

The effectiveness and side effects of cyclophosphamide, paclitaxel, and trastuzumab are being tested after surgery in patients with early-stage HER2-positive breast cancer. The goal is to prevent cancer recurrence by using these chemotherapy drugs and a monoclonal antibody.

What are the potential side effects?

Potential side effects include nausea, hair loss, fatigue from chemotherapy drugs like cyclophosphamide and paclitaxel; allergic reactions or heart issues may occur due to trastuzumab.

Eligibility Criteria

Inclusion Criteria

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

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My heart pumps well, with an ejection fraction over 50%.

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I have been newly diagnosed with early-stage HER2 positive breast cancer.

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I am not pregnant or nursing and agree to use birth control during and up to 6 months after the study.

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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 am able to follow the treatment plan as directed.

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

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I have had chemotherapy in the past.

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My breast cancer has spread to other parts of my body.

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I do not have any serious infections or conditions that would prevent me from receiving chemotherapy.

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I do not have HIV or active hepatitis.

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

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

Incidence of grade 3/4 cardiotoxicity, graded according to the NCI CTCAE v4.03

Incidence of grade 3/4 nausea/vomiting, graded according to the NCI CTCAE v4.03

Incidence of inability to complete treatment, defined as a patient that requires a lower dose of therapy (defined as dose lowered by 50%), or a postponement of scheduled treatment of longer than 28 days, or discontinuation of treatment for any reason

+3 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cyclophosphamide, paclitaxel, trastuzumab)Experimental Treatment4 Interventions

SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Paclitaxel

FDA approved

Trastuzumab

FDA approved

0 / 11Eligibility criteria met