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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
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.Check my eligibility
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.See study design
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 belowSelect...
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pCR Rate
Secondary outcome measures
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 moreTrial 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
~5380
Lapatinib Ditosylate
2006
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,096 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Lisa A CareyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is at stage III and has been checked for spread.My tumor is HER2 positive, confirmed by specific tests.I haven't received any treatment for this cancer.I have been diagnosed with invasive breast cancer, not inflammatory breast cancer.I am a woman not pregnant, post-hysterectomy, menopausal, or haven't had a period for 24 months.I know my cancer's estrogen and progesterone receptor status.Your heart's pumping function must be at least 50% as measured by certain tests.Your bilirubin level is not more than 1.5 times the upper limit of normal.I am fully active or can carry out light work.Your AST and ALT levels are not more than 2.5 times the normal limit.I have cancer in more than one location, but it meets the study's criteria.I have stage II-III breast cancer and plan to have surgery after initial treatment.My breast tumor is at least 1 cm large, and I don't have cancer only in my underarm lymph nodes.You have enough infection-fighting white blood cells in your body.Your platelet count is 100,000 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (TL)
- Group 2: Arm I (THL)
- Group 3: Arm II (TH)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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