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Lapatinib in Endocrine-Resistant Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Lapatinib in Endocrine-Resistant Metastatic Breast Cancer

All patients must have stopped their endocrine two to four weeks or longer prior to entry on
study. Upon enrollment, patients will begin lapatinib at 1500 mg once a day orally. The
original endocrine therapy will resume two weeks later. The lapatinib will be continued for
a maximum of 26 weeks.

A history, physical examination, blood counts, and chemistries will be done at baseline, and
at regular intervals through the course of the study. A CT scan and bone scan will be done
prior to treatment and at weeks 14 and 26. Assays for plasma DNA will be performed on
blood sampled at baseline and at multiple time points throughout the course of treatment.
Percutaneous biopsies will be taken in selected patients with accessible disease, 72 hours
or less prior to the start of lapatinib, and again 13-15 days, and 27-29 days following the
start of lapatinib. The day 13-15 biopsy will be done just prior to the resumption of the
patient's endocrine therapy. Assays for phospho-ERK, phospho-Akt, Cyclin D1, Ki-67, and
IRS-1 will be performed by conventional immunohistochemistry on the biopsied tissue.

Inclusion Criteria:

- Patients with histologically or cytologically proven metastatic breast cancer.

- Patients with either estrogen or progesterone receptor positivity on the most
recently examined tumor biopsy.

- Patients must have most recently been using an anti-estrogen (tamoxifen, toremifene,
raloxifene, or fulvestrant) or an aromatase inhibitor.

- Patients must have had either a partial response or better, or stable disease for 24
weeks or longer, followed by disease progression, on the current or most recent
hormonal therapy for management of metastatic breast cancer.

- Patients must be enrolled within six weeks of defining disease progression on
hormonal therapy.

- Patients must have stopped fulvestrant at least four weeks prior and other endocrine
therapy at least two weeks prior to enrollment on study.

- Patients must have either measurable disease or at least one evaluable bone lesion
that has not been irradiated. Measurable disease is not necessary.

- Estimated life expectancy of at least 6 months.

- ECOG performance status 0-2.

- Adequate hematologic, hepatic, and renal function.

- Patients must be post-menopausal, or they must be practicing either abstinence or an
adequate method of contraception, or their sexual partner must be sterile.

- All patients must be able to swallow, retain, and absorb oral medications.

- All patients must be able to give informed consent indicating that they are aware of
the investigational nature of this study.

Exclusion Criteria:

- Patients may not have received an investigational agent within the prior four weeks.

- Patients may not have received trastuzumab within three weeks of study entry.

- Patients may not have had major surgery within the prior two weeks.

- Patients may not have Class III or IV heart failure as defined by the NYHA functional
classification system.

- Patients may not have a left ventricular ejection fraction < 40% based on MUGA or

- Patients may not have uncontrolled brain metastases or leptomeningeal disease.

- Patients may not have rapidly progressive visceral metastases.

- Patients may not have a serious illness or conditions including clinically
significant cardiac disease, angina pectoris, serious psychiatric disorder, or an
active infection.

- Patients may not be receiving concurrent medications (listed in the protocol) which
may interact with lapatinib during treatment with lapatinib.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the response rate and progression free survival of hormone therapy-resistant patients with metastatic breast cancer treated with the same continued hormonal agent with the addition of lapatinib.

Outcome Time Frame:

26 weeks

Safety Issue:


Principal Investigator

Gary N Schwartz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

October 2011

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • endocrine therapy
  • drug resistance
  • lapatinib
  • epidermal growth factor receptor
  • Breast Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
North Shore University Hospital Manhasset, New York  11030