Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer

NCT00424164 | Completed Phase 1

• 2 other identifiers: EORTC-100532005-005196-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer. PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination

  maximum 24h after the dose administered on Day 28

Secondary Outcomes (3)

• Safety

  until disease progression or until the start of another treatment (average 2 months)

• Relationship between drug exposure and adverse events or biological modifications

  until disease progression or until the start of another treatment (average 2 months)

• Response in patients with measurable disease

  until disease progression or until the start of another treatment (average 2 months)

Study Arms (2)

Tamoxifen-lapatinib

EXPERIMENTAL

Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.

Drug: lapatinib ditosylate; Drug: tamoxifen citrate; Other: pharmacological study

Lapatinib-tamoxifen

EXPERIMENTAL

Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen

Drug: lapatinib ditosylate; Drug: tamoxifen citrate; Other: pharmacological study

Interventions

lapatinib ditosylate DRUG

Lapatinib-tamoxifen; Tamoxifen-lapatinib

tamoxifen citrate DRUG

Lapatinib-tamoxifen; Tamoxifen-lapatinib

pharmacological study OTHER

Lapatinib-tamoxifen; Tamoxifen-lapatinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic breast cancer * Progressive disease after aromatase inhibitor therapy * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-positive tumor * Patients with stable brain metastases (i.e., no neurological symptoms and no corticosteroid treatment) are eligible PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * AST and/or ALT \< 3 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * Bilirubin \< 1.5 times ULN * Clinically normal cardiac function (i.e., LVEF normal by MUGA or ECHO) * No current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic live disease) * No ischemic heart disease within the past 6 months * Normal 12-lead ECG * No active or uncontrolled infections * No serious illnesses or medical conditions, including any of the following: * Hypercalcemia * Malabsorption syndrome * Chronic alcohol abuse * Hepatitis * HIV * Cirrhosis * Able to swallow and retain oral medication * No psychological, familial, sociological, or geographical condition potentially hampering study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 days since prior and no concurrent inducers or inhibitors of CYP3A4, including any of the following: * Rifabutin * Clarithromycin * Cyclosporine * Voriconazole * Fluoxetine * Paroxetine * Midazolam * Isoniazid * Dihydralazine * Digitoxin * Coumadin * Phenytoin * Verapamil * Diltiazem * Herbal constituents (e.g., bergamottin and glabridin) * At least 2 weeks since prior aromatase inhibitor * Aromatase inhibitors in the adjuvant and/or metastatic setting allowed * At least 1 year since prior tamoxifen citrate * No other concurrent anticancer therapy or investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Centre Regional Rene Gauducheau

Dijon, 21079, France

Location

Related Publications (1)

• Fumoleau P, Koch KM, Brain E, Lokiec F, Rezai K, Awada A, Hayward L, Werutsky G, Bogaerts J, Marreaud S, Cardoso F. A phase I pharmacokinetics study of lapatinib and tamoxifen in metastatic breast cancer (EORTC 10053 Lapatam study). Breast. 2014 Oct;23(5):663-9. doi: 10.1016/j.breast.2014.07.003. Epub 2014 Jul 24.

  PMID: 25065668 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Lapatinib; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pierre Fumoleau, MD, PhD

  Centre Georges Francois Leclerc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: May 28, 2010
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

FR (1)