Trastuzumab for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Cancer+7 More
Trastuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Breast Cancer
  • Breast
  • Malignant neoplasm of breast

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Breast Cancer

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Time from surgery to any recurrence (up to 10 years)

At time of surgery
Pathologic Stage in the Breast and Axilla
pCR Rate
Year 10
Overall Survival
Year 10
Time to First Failure
Year 10
Relapse-free Survival (RFS)
Day 30
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3
Week 16
Radiographic Response Rate (at Completion of Neoadjuvant Therapy)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Breast Cancer

Trial Design

3 Treatment Groups

Arm II (TH)
1 of 3
Arm I (THL)
1 of 3
Arm III (TL)
1 of 3
Active Control
Experimental Treatment

305 Total Participants · 3 Treatment Groups

Primary Treatment: Trastuzumab · No Placebo Group · Phase 3

Arm I (THL)Experimental Group · 4 Interventions: Lapatinib Ditosylate, Trastuzumab, Laboratory Biomarker Analysis, Paclitaxel · Intervention Types: Drug, Biological, Other, Drug
Arm III (TL)Experimental Group · 2 Interventions: Lapatinib Ditosylate, Paclitaxel · Intervention Types: Drug, Drug
Arm II (TH)ActiveComparator Group · 3 Interventions: Trastuzumab, Laboratory Biomarker Analysis, Paclitaxel · Intervention Types: Biological, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lapatinib
FDA approved
Trastuzumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from surgery to any recurrence (up to 10 years)

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,583 Total Patients Enrolled
923 Trials studying Breast Cancer
1,535,609 Patients Enrolled for Breast Cancer
Lisa A CareyPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Target lesions in the breast must be >= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate.
to monitor response to therapy The patient agrees to provide biopsies of the treatment area before and after treatment to monitor the response to the therapy.
The patient has not received any chemotherapy, hormone therapy, biologic therapy, or radiation therapy with therapeutic intent for this cancer.
Pathologic confirmation of breast cancer is required; patients with inflammatory breast cancer are not eligible.
This text is about a woman who has breast cancer that is at stage II or III
with a high suspicion for metastatic disease
The tumor must be positive for the HER2 protein, as determined by an immunohistochemical assay or a gene amplification assay, with a HER2 to tumor cell ratio of greater than or equal to 2
The cardiac ejection fraction must be >= 50% by either an echocardiogram or a multiple gated acquisition (MUGA) scan.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.