Clinical Trial: Lapatinib and Tamoxifen in Treating Patients with Locally Advanced Or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

This study is currently recruiting patients.

Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Sometimes when tamoxifen is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen. Giving lapatinib together with tamoxifen may reduce drug resistance and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving lapatinib together with tamoxifen works in treating patients with locally advanced or metastatic breast cancer that did not respond to previous tamoxifen.

Condition Intervention Phase
stage IV breast cancer
recurrent breast cancer
Male Breast Cancer
stage IIIB breast cancer
stage IIIC breast cancer
 Drug: lapatinib
 Drug: tamoxifen
 Procedure: antiestrogen therapy
 Procedure: drug resistance inhibition
 Procedure: endocrine therapy
 Procedure: enzyme inhibitor therapy
 Procedure: hormone therapy
 Procedure: protein tyrosine kinase inhibitor therapy
Phase II

MedlinePlus related topics:  Breast Cancer;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Lapatinib and Tamoxifen in Patients with Tamoxifen-Resistant Locally Advanced Or Metastatic Breast Cancer

Further Study Details: 


OUTLINE: This is a multicenter study.

Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 13-21 months.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • ALT and AST ≤ 1.5 times upper limit normal (ULN) (3 times ULN if liver metastases are present)
  • Bilirubin ≤ 1.5 times ULN


  • Creatinine normal OR
  • Creatinine clearance > 60 mL/min


  • Ejection fraction normal by echocardiogram or MUGA
  • None of the following cardiovascular conditions within the past 6 months:
  • Myocardial infarction
  • Severe or unstable angina
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Deep venous thrombosis or other clinically significant thromboembolic event within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy


  • Pulmonary embolus within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy


  • No malabsorption syndrome
  • No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
  • No requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn''''s disease or ulcerative colitis)
  • Able to swallow and retain oral medication


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for ≥ 2 weeks after completion of study treatment
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation


  • Prior trastuzumab (Herceptin®) in combination with chemotherapy in the adjuvant setting only is allowed
  • No prior trastuzumab in combination with hormonal therapy
  • No concurrent trastuzumab


Endocrine therapy

  • See Disease Characteristics
  • See Biologic therapy
  • Prior first-line aromatase inhibitors for metastatic disease allowed provided the aromatase inhibitors were administered before initiation of prior tamoxifen treatment AND no other hormonal therapy was administered after failing tamoxifen
  • At least 14 days since prior and no concurrent dexamethasone or dexamethasone equivalent dose > 1.5 mg/day


  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy


  • More than 4 weeks since prior surgery
  • More than 6 months since prior coronary or peripheral artery bypass grafting
  • No prior surgical procedure affecting absorption


  • No prior epidermal growth factor receptor- or HER2/neu-targeting therapies
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Itraconazole
  • Ketoconazole
  • Voriconazole
  • Fluconazole (doses ≤ 150 mg/day allowed)
  • Fluvoxamine
  • Nefazodone
  • Verapamil
  • Diltiazem
  • Cimetidine
  • Aprepitant
  • Proton pump inhibitors
  • H2 blockers
  • Grapefruit or grapefruit juice
  • Bitter orange
  • At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Oxcarbazepine
  • Efavirenz
  • Nevirapine
  • Rifampin
  • Rifabutin
  • Rifapentine
  • Hypericum perforatum (St. John''''s wort)
  • Modafinil
  • At least 6 months since prior and no concurrent amiodarone
  • No concurrent gastric pH modifiers within 1 hour before and after lapatinib administration
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent antineoplastic agents
  • No other concurrent investigational agents
  • Concurrent zoledronate for bone metastases or hypercalcemia allowed
  • Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in INR monitoring

Location and Contact Information

Please refer to this study by identifier  NCT00118157

      Kapiolani Medical Center for Women and Children, Honolulu,  Hawaii,  96826,  United States; Recruiting
Jennifer B. Day, MD  808-983-6090 

      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Elaina M. Gartner, MD  313-745-9155 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
Paula Silverman, MD  216-844-8510 

Study chairs or principal investigators

Elaina M. Gartner, MD,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000433388; WSU-C-2876; NCI-6724; NCT00118157
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 8, 2005 Identifier:  NCT00118157
Health Authority: United States: Federal Government processed this record on 2005-07-26

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