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The Feasibility of Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

Phase 2
18 Years
Open (Enrolling)
HER2-Positive Early Stage Breast Cancer

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Trial Information

The Feasibility of Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

Inclusion Criteria:

- Patients must have histologically confirmed adenocarcinoma with HER2/neu
immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of > 2.0

- Tumor size of < 3 cm and node-negative disease. Nodes with single cells or tumor
clusters < 0.2 mm by H&E or IHC are considered node-negative. Patients with
micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed.
Further axillary dissection will be determined by the patient's surgeon as per
standard of care.

- Patients must be ≥18 years of age.

- Patients must have an ECOG performance status of 0 or 1.

- Treatment should be started within 90 days of the final surgical procedure for breast

- Patients may have bilateral synchronous breast tumors. Patients may have received
hormonal therapy for the purpose of chemoprevention but must be willing to
discontinue prior to enrollment and while participating in this trial.

- If patients have peripheral neuropathy, it must be < grade 1.

- Patients must be willing to discontinue sex hormonal therapy e.g., birth control
pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of
childbearing potential must be willing to consent to using effective contraception
while on treatment and for a reasonable period thereafter.

- Hematologic parameters: absolute neutrophil count (ANC) ≥1500/μL and platelet count

- Non-hematologic parameters: total bilirubin must be < 1.5 X institutional upper limit
of normal (ULN), transaminases (SGOT or SGPT) < 3.0 x ULN.

- Negative HCG pregnancy test for premenopausal women of reproductive capacity and for
women less than 12 months after the menopause. LVEF by ECHO (with strain if possible)
with LVEF of > 50%. If an ECHO cannot be done, a MUGA may be performed.

- Patients must give written, informed consent indicating their understanding of and
willingness to participate in the study.

Exclusion Criteria:

- Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy,
immunotherapy, or biotherapy for current breast cancer.

- Pregnant or breastfeeding patients.

- Patients with a concurrently active second malignancy, other than adequately treated
non-melanoma skin cancers or in situ cervical cancer.

- Patients with unstable angina, congestive heart failure, or with a history of a
myocardial infarction within 12 months. Patients with high-risk uncontrolled
arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular
arrhythmias which are not adequately rate-controlled). Patients are excluded if they
have grade 3 QT prolongation (Appendix F) (>500 ms) or require drugs that may prolong
the QT.

- Subjects who have current active hepatic (including hepatitis B or C) or biliary
disease (with exception of patients with Gilbert's syndrome, asymptomatic

- Patients with active, unresolved infections.

- Patients with a sensitivity to E. coli derived proteins.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Chau Dang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • HER2-Positive Early Stage Breast Cancer
  • Paclitaxel
  • Trastuzumab
  • Lapatinib
  • HER2
  • 13-002
  • Breast Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York