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Taxane

Paclitaxel + Trastuzumab +/- Lapatinib for Breast Cancer

Phase 3

Waitlist Available

Led By Lisa A Carey

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

Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2 on invasive tumor

No prior chemotherapy, hormone therapy, biologic, or radiation therapy with therapeutic intent for this cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from surgery to any recurrence (up to 10 years)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing paclitaxel with trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer.

Who is the study for?

This trial is for patients with stage II or III breast cancer that can be surgically removed. Participants must not have metastatic disease, should have normal liver function and heart health, know their hormone receptor status, agree to provide biopsies, and not be pregnant or breastfeeding. Prior treatments for this cancer are disallowed. Tumors must be HER2 positive.

What is being tested?

The study tests the effectiveness of paclitaxel and trastuzumab with or without lapatinib before surgery in shrinking tumors. Paclitaxel is a chemotherapy drug; trastuzumab is a monoclonal antibody blocking tumor growth; lapatinib inhibits enzymes needed by tumor cells.

What are the potential side effects?

Possible side effects include allergic reactions to drugs, fatigue from chemotherapy, heart issues due to trastuzumab, diarrhea from lapatinib, as well as potential blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is HER2 positive, confirmed by specific tests.

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I haven't received any treatment for this cancer.

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I have been diagnosed with invasive breast cancer, not inflammatory breast cancer.

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I know my cancer's estrogen and progesterone receptor status.

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I am fully active or can carry out light work.

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I have stage II-III breast cancer and plan to have surgery after initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from surgery to any recurrence (up to 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from surgery to any recurrence (up to 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from surgery to any recurrence (up to 10 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

pCR Rate

Secondary study objectives

Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3

Overall Survival

Pathologic Stage in the Breast and Axilla

+3 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (TL)Experimental Treatment2 Interventions

Patients receive paclitaxel 80 mg/m\^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)

Group II: Arm I (THL)Experimental Treatment4 Interventions

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m\^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.

Group III: Arm II (TH)Active Control3 Interventions

Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m\^2 IV over 1 hour once weekly for 16 weeks 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

Paclitaxel

2011

Completed Phase 4

~5370