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Alkylating agents

Group 2: AC then paclitaxel + lapatinib for Breast Cancer

Phase 3
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 20 Other Conditions
No Placebo-Only Group

Summary

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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: Group 3: AC then paclitaxel + trastuzumab + lapatinibExperimental Treatment5 Interventions
AC followed by paclitaxel plus trastuzumab plus lapatinib
Group II: Group 2: AC then paclitaxel + lapatinibExperimental Treatment4 Interventions
AC followed by paclitaxel plus lapatinib
Group III: Group 1: AC then paclitaxel + trastuzumabActive Control4 Interventions
AC followed by paclitaxel plus trastuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Lapatinib
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

NSABP Foundation IncLead Sponsor
88 Previous Clinical Trials
139,773 Total Patients Enrolled
46 Trials studying Breast Cancer
102,330 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,802 Previous Clinical Trials
8,377,473 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,269 Patients Enrolled for Breast Cancer
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
83,188 Total Patients Enrolled
30 Trials studying Breast Cancer
68,865 Patients Enrolled for Breast Cancer
~29 spots leftby Nov 2025
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