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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 through 5 years after entry
Awards & highlights

Study 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 ~two year cumulative incidence
This trial's timeline: 3 weeks for screening, Varies for treatment, and two year cumulative incidence for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen.
Secondary outcome measures
Clinical tumor measurement as assessed by physical exam of the breast and lymph nodes
Determination of cardiac toxicity as measured by the incidence of cardiac events defined as definite or probable cardiac death
Determination of non-cardiac toxicities as measured by frequencies of adverse events categorized using CTCAE v3.0.
+4 more

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
Lapatinib
FDA approved
Trastuzumab
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
136,459 Total Patients Enrolled
45 Trials studying Breast Cancer
100,530 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,749 Previous Clinical Trials
8,066,947 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer
2007. "A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00486668.
All > Acl > Breast
~30 spots leftby Apr 2025
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