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Alkylating agents

Chemotherapy + Trastuzumab for Breast Cancer

Phase 3

Waitlist Available

Led By Louis Fehrenbacher

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination

Submission of tumor samples from the breast surgery is required for all patients

Must not have

Synchronous or previous contralateral invasive breast cancer

Continued endocrine therapy such as raloxifene or tamoxifen or an aromatase inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying giving chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.

Who is the study for?

This trial is for women with invasive breast cancer who've had surgery. They must have a life expectancy of at least 10 years, not counting their cancer, and be in good health otherwise. Participants need proper organ function and no history of certain cancers or treatments within the last 5 years. Women must agree to avoid pregnancy during and after the trial for specified periods.

What is being tested?

The study compares chemotherapy alone versus chemotherapy with trastuzumab (a monoclonal antibody) post-surgery in treating breast cancer. It aims to determine if adding trastuzumab improves outcomes by preventing tumor growth or spread more effectively than chemotherapy alone.

What are the potential side effects?

Chemotherapy can cause nausea, hair loss, fatigue, increased risk of infection, and other side effects depending on the drugs used. Trastuzumab may lead to heart problems, allergic reactions, flu-like symptoms, headache, trouble sleeping, and dizziness.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is invasive and only in one breast.

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I have provided tumor samples from my breast surgery.

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My cancer stage fits the specific criteria set by the AJCC 7th edition.

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My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.

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My last breast cancer surgery was within the last 84 days.

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I have had either a total mastectomy or a lumpectomy.

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I have had a procedure to check the status of my lymph nodes.

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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 have had breast cancer in both breasts at the same time or at different times.

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I am currently on hormone therapy for my cancer.

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My diabetes is not well-managed.

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I am currently using hormone therapy.

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I cannot take corticosteroids due to my health condition.

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I take 10 mg or more of corticosteroids daily.

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I have received chemotherapy or HER2 therapy for my current breast cancer.

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I have had breast cancer or DCIS on the same side before.

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My cancer has spread to other parts of my body.

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My heart condition allows me to use the drugs in the treatment plan.

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My blood pressure is not too high based on specific criteria.

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I have a lung condition that makes it hard for me to breathe.

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I have been treated with anthracyclines, taxanes, or trastuzumab for cancer.

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My primary tumor was tested for HER2.

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I have active hepatitis B or C with abnormal liver tests.

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I have an ongoing infection or need long-term antibiotics.

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I have a moderate to severe nervous system condition.

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I have had or will have whole or partial breast radiation before joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Percentage of Patients Alive and Free From Invasive Disease (IDFS)

Secondary study objectives

Change in HER2 mRNA Level

Fcgamma Receptor Polymorphism

Percentage of Patients Alive (Overall Survival)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (chemotherapy, trastuzumab)Experimental Treatment8 Interventions

GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (chemotherapy)Active Control7 Interventions

GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Cyclophosphamide

2010

Completed Phase 4

~2310