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

Recruiting in Palo Alto (17 mi)

+109 other locations

Overseen by Norman Wolmark, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NSABP Foundation Inc

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Norman Wolmark, MD

Principal Investigator

NSABP Foundation Inc

Eligibility Criteria

Inclusion Criteria

18 years or older

ECOG performance status of 0 or 1

Primary breast tumor palpable and measures greater than or equal to 2.0 cm by physical exam

Treatment Details

Interventions

• Cyclophosphamide (Alkylating agents)
• Doxorubicin (Anti-tumor antibiotic)
• Lapatinib (Small Molecule)
• Quality-of-Life Assessment (Other)
• Trastuzumab (Monoclonal Antibodies)

Participant Groups

Group I: Group 3: AC then paclitaxel + trastuzumab + lapatinib Experimental Treatment 5 Interventions

AC followed by paclitaxel plus trastuzumab plus lapatinib

Group II: Group 2: AC then paclitaxel + lapatinib Experimental Treatment 4 Interventions

AC followed by paclitaxel plus lapatinib

Group III: Group 1: AC then paclitaxel + trastuzumab Active Control 4 Interventions

AC followed by paclitaxel plus trastuzumab

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

NSABP Foundation Inc

Lead Sponsor

Trials

89

Recruited

140,000+

Priya Rastogi

NSABP Foundation Inc

Chief Executive Officer since 2022

MD from University of Pittsburgh

Charles E. Geyer Jr.

NSABP Foundation Inc

Chief Medical Officer since 2022

MD from Texas Tech University

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School