Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

NCT ID: NCT00073528

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-09
• Study Completion Date: 2018-03-22

Brief Summary

This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

Detailed Description

Subjects were randomly assigned to receive either lapatinib (1500 mg once daily orally) with letrozole (2.5 mg once daily orally), or letrozole (2.5 mg once daily orally) with placebo (which matched with lapatinib tablet). Randomization was stratified by site of disease (i.e., soft tissue/visceral disease versus bone only disease) and time since prior adjuvant endocrine therapy (<6 months or ≥ 6 months from discontinuation of adjuvant anti-estrogen therapy (e.g. tamoxifen or raloxifene) or no prior adjuvant antiestrogen therapy). Study therapy was administered daily until disease progression (objective or symptomatic) or withdrawal from therapy (e.g., due to unacceptable toxicity, withdrawal of consent, or other reason). All subjects were to be followed for survival information until death.

On 13 Apr 2015, after the introduction of the Long Term Follow UP (LTFU) phase (per protocol amendment 07), subjects receiving study treatment with lapatinib plus letrozole, or letrozole plus placebo had continued access to this study treatment until the occurrence of one of the following criteria:

• Disease progression (as determined by the Investigator),
• Intercurrent illness that prevented further administration of study treatment
• Drug related AE which was considered by the investigator to warrant permanent discontinuation of study treatment
• The subject decided to withdraw from the study. Investigators collected AEs and/or SAEs related to study participation, until 30 days following study treatment discontinuation. Subjects who were being followed-up for OS but were not taking study medication, were withdrawn from the study.

The study was terminated on 22-Mar-2018 (last subject last visit).

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo + Letrozole 2.5 mg

Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)

Group Type: PLACEBO_COMPARATOR

Letrozole

Intervention Type: DRUG

2.5 mg orally once a day

Placebo

Intervention Type: DRUG

Placebo (which matched with lapatinib tablet)

Lapatinib 1500 mg + Letrozole 2.5 mg

Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)

Group Type: EXPERIMENTAL

Lapatinib

Intervention Type: DRUG

1500 mg orally once a day

Letrozole

Intervention Type: DRUG

2.5 mg orally once a day

Interventions

Lapatinib

1500 mg orally once a day

Intervention Type: DRUG

Letrozole

2.5 mg orally once a day

Intervention Type: DRUG

Placebo

Placebo (which matched with lapatinib tablet)

Intervention Type: DRUG

Other Intervention Names

GW572016

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent;

2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;

• Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
• If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.

3. Tumors that were ER+ and/or PgR+;

4. Post-menopausal female subjects ≥ 18 years of age.

5. ECOG Performance Status of 0 or 1;

6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.

7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.

8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.

Exclusion Criteria

1. Pre-menopausal, pregnant, or lactating;

2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;

3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;

4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);

5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)

6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Alhambra, California, United States

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Bakersfield, California, United States

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Duarte, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Montebello, California, United States

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Northridge, California, United States

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Oxnard, California, United States

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Pleasant Hill, California, United States

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Porterville, California, United States

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Redondo Beach, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Santa Maria, California, United States

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Vallejo, California, United States

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Vista, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Wheat Ridge, Colorado, United States

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New Haven, Connecticut, United States

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Boca Raton, Florida, United States

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Boca Raton, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Lakeland, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Port Saint Lucie, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Peoria, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Bettendorf, Iowa, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Voorhees Township, New Jersey, United States

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Santa Fe, New Mexico, United States

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Manhasset, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Greenville, North Carolina, United States

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Fargo, North Dakota, United States

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Canton, Ohio, United States

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Hershey, Pennsylvania, United States

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Irving, Texas, United States

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Seattle, Washington, United States

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Charleston, West Virginia, United States

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Garran, Australian Capital Territory, Australia

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Douglas, Queensland, Australia

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Herston, Queensland, Australia

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Redcliffe, Queensland, Australia

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Adelaide, South Australia, Australia

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Salvador, Estado de Bahia, Brazil

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Winnipeg, Manitoba, Canada

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Greater Sudbury, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oshawa, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Bogotá, , Colombia

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Osijek, , Croatia

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Split, , Croatia

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Brno, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Hillerød, , Denmark

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Koebenhavn Oe, , Denmark

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Næstved, , Denmark

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Roskilde, , Denmark

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Besançon, , France

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Grenoble, , France

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Montpellier, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Schwetzingen, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Augsburg, Bavaria, Germany

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Bayreuth, Bavaria, Germany

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Erlangen, Bavaria, Germany

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Rehling, Bavaria, Germany

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Rosenheim, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Goslar, Lower Saxony, Germany

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Leer, Lower Saxony, Germany

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Bonn, North Rhine-Westphalia, Germany

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Coesfeld, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Ibbenbueren, North Rhine-Westphalia, Germany

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Velbert, North Rhine-Westphalia, Germany

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Altenkirchen, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Dresden, Saxony, Germany

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Kiel, Schleswig-Holstein, Germany

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Pinneberg, Schleswig-Holstein, Germany

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Hamburg, , Germany

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Galway, , Ireland

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Tallaght, Dublin, , Ireland

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Wilton, Cork, , Ireland

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Milan, Lombardy, Italy

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Colima, , Mexico

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Mexico City, , Mexico

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Amersfoort, , Netherlands

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Delft, , Netherlands

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Doetinchem, , Netherlands

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Eindhoven, , Netherlands

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Heerlen, , Netherlands

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Leidschendam, , Netherlands

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Maastricht, , Netherlands

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Nieuwegein, , Netherlands

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Sittard-geleen, , Netherlands

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The Hague, , Netherlands

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The Hague, , Netherlands

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Utrecht, , Netherlands

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Utrecht, , Netherlands

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Christchurch, , New Zealand

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Lahore, , Pakistan

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Lahore, , Pakistan

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Rawalpindi, , Pakistan

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Callao, , Peru

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Lima, , Peru

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Bydogoszcz, , Poland

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Krakow, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Capital Park, , South Africa

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Panorama, , South Africa

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Parktown, , South Africa

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Port Elizabeth, , South Africa

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Gyeonggi-do, , South Korea

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Seodaemun-gu, Seoul, , South Korea

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Seoul, , South Korea

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Alcala de Henares (Madrid), , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

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Elche, , Spain

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Girona, , Spain

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Leganes, Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Móstoles, , Spain

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Oviedo, , Spain

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Palma de Mallorca, , Spain

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Valencia, , Spain

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Vigo ( Pontevedra), , Spain

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Zaragoza, , Spain

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Sfax, , Tunisia

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Sousse, , Tunisia

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Tunis, , Tunisia

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Tunis, , Tunisia

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Chelmsford, Essex, United Kingdom

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Manchester, Lancashire, United Kingdom

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Northwood, Middlesex, United Kingdom

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Sutton, Surrey, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Huddersfield, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Sheffield, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Chile; Colombia; Croatia; Czechia; Denmark; France; Germany; Hungary; Ireland; Italy; Mexico; Netherlands; New Zealand; Pakistan; Peru; Poland; Russia; South Africa; South Korea; Spain; Tunisia; Turkey (Türkiye); United Kingdom

References

Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

Reference Type: BACKGROUND

PMID: 19786658 (View on PubMed)

Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15.

Reference Type: BACKGROUND

PMID: 20156908 (View on PubMed)

Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.

Reference Type: BACKGROUND

PMID: 20798196 (View on PubMed)

Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.

Reference Type: BACKGROUND

PMID: 24198242 (View on PubMed)

Prat A, Cheang MC, Galvan P, Nuciforo P, Pare L, Adamo B, Munoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922.

Reference Type: BACKGROUND

PMID: 27281556 (View on PubMed)

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

Reference Type: DERIVED

PMID: 29522361 (View on PubMed)

Other Identifiers

CLAP016A2308

Identifier Type: OTHER

Identifier Source: secondary_id

2004-003928-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EGF30008

Identifier Type: -

Identifier Source: org_study_id

NCT00084968

Identifier Type: -

Identifier Source: nct_alias