AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT00073528

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

A Phase 3 study testing Lapatinib and Letrozole in people with Breast Neoplasms, run by Novartis Pharmaceuticals at 278 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Lapatinib and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,286 participants
Where
278 sitesin 29 countries
Study dates
9 Dec 2003to 22 Mar 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent;
  • 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.
  • Tumors that were ER+ and/or PgR+;
  • Post-menopausal female subjects ≥ 18 years of age.
Show all 10Show fewer
  • ECOG Performance Status of 0 or 1;
  • Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
  • 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.
  • Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.

Who cannot join

  • Pre-menopausal, pregnant, or lactating;
  • Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
  • 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;
  • Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
  • 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.)
  • Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.

Trial locations and contacts

278 sites in 29 countries.

278 sites in 29 countries

United States84 sites

  • Novartis Investigative Site

    Alhambra, California, 91801

  • Novartis Investigative Site

    Amarillo, Texas, 79106

  • Novartis Investigative Site

    Atlanta, Georgia, 30341

  • Novartis Investigative Site

    Aurora, Colorado, 80045

  • Novartis Investigative Site

    Bakersfield, California, 93309

  • Novartis Investigative Site

    Bettendorf, Iowa, 52722

  • Novartis Investigative Site

    Boca Raton, Florida, 33428

  • Novartis Investigative Site

    Boca Raton, Florida, 33486

  • Novartis Investigative Site

    Burlington, Vermont, 05401

  • Novartis Investigative Site

    Canton, Ohio, 44718

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599-7305

  • Novartis Investigative Site

    Charleston, West Virginia, 25304

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Dallas, Texas, 75390-9113

  • Novartis Investigative Site

    Danville, Virginia, 24541

  • Novartis Investigative Site

    Denver, Colorado, 80220

  • Novartis Investigative Site

    Duarte, California, 91010

  • Novartis Investigative Site

    Duluth, Minnesota, 55805

  • Novartis Investigative Site

    Fargo, North Dakota, 58103

  • Novartis Investigative Site

    Fountain Valley, California, 92708

  • Novartis Investigative Site

    Fresno, California, 93710

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Gainesville, Florida, 32605

  • Novartis Investigative Site

    Gainesville, Florida, 32610

  • Novartis Investigative Site

    Germantown, Tennessee, 38138

  • Novartis Investigative Site

    Greenville, North Carolina, 27834

  • Novartis Investigative Site

    Hershey, Pennsylvania, 17033

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Hot Springs, Arkansas, 71913

  • Novartis Investigative Site

    Houston, Texas, 77025

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Irving, Texas, 75061

  • Novartis Investigative Site

    Jonesboro, Arkansas, 72401

  • Novartis Investigative Site

    Knoxville, Tennessee, 37916

  • Novartis Investigative Site

    La Jolla, California, 92093-0987

  • Novartis Investigative Site

    Lakeland, Florida, 33805

  • Novartis Investigative Site

    Las Vegas, Nevada, 89169

  • Novartis Investigative Site

    Long Beach, California, 90813

  • Novartis Investigative Site

    Longmont, Colorado, 80501

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    Manhasset, New York, 11030

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Miami, Florida, 33136

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407-3799

  • Novartis Investigative Site

    Montebello, California, 90640

  • Novartis Investigative Site

    New Haven, Connecticut, 06520

  • Novartis Investigative Site

    New Orleans, Louisiana, 70121

  • Novartis Investigative Site

    Northridge, California, 91325

  • Novartis Investigative Site

    Ogden, Utah, 84403

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Orlando, Florida, 32804

  • Novartis Investigative Site

    Oxnard, California, 93030

  • Novartis Investigative Site

    Peoria, Illinois, 61615

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19111

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15212

  • Novartis Investigative Site

    Pleasant Hill, California, 94523

  • Novartis Investigative Site

    Port Saint Lucie, Florida, 34952

  • Novartis Investigative Site

    Porterville, California, 93257

  • Novartis Investigative Site

    Redondo Beach, California, 90277

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Robbinsdale, Minnesota, 55422

  • Novartis Investigative Site

    Rochester, New York, 14623

  • Novartis Investigative Site

    Saint Charles, Missouri, 63304

  • Novartis Investigative Site

    Saint Louis Park, Minnesota, 55426

  • Novartis Investigative Site

    Salt Lake City, Utah, 84106

  • Novartis Investigative Site

    San Diego, California, 92120

  • Novartis Investigative Site

    Santa Barbara, California, 93105

  • Novartis Investigative Site

    Santa Fe, New Mexico, 87505

  • Novartis Investigative Site

    Santa Maria, California, 93454

  • Novartis Investigative Site

    Savannah, Georgia, 31406

  • Novartis Investigative Site

    Seattle, Washington, 98104

  • Novartis Investigative Site

    Skokie, Illinois, 60076

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tucson, Arizona, 85715

  • Novartis Investigative Site

    Vallejo, California, 94589

  • Novartis Investigative Site

    Vista, California, 92081

  • Novartis Investigative Site

    Voorhees Township, New Jersey, 08043

  • Novartis Investigative Site

    West Columbia, South Carolina, 29210

  • Novartis Investigative Site

    West Palm Beach, Florida, 33401

  • Novartis Investigative Site

    Wheat Ridge, Colorado, 80033

  • Novartis Investigative Site

    Worcester, Massachusetts, 01608

Other trials in United States

Germany45 sites

  • Novartis Investigative Site

    Aalen, Baden-Wurttemberg, 73428

  • Novartis Investigative Site

    Altenkirchen, Rhineland-Palatinate, 57610

  • Novartis Investigative Site

    Augsburg, Bavaria, 86150

  • Novartis Investigative Site

    Bayreuth, Bavaria, 95445

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 10317

  • Novartis Investigative Site

    Berlin, 12200

  • Novartis Investigative Site

    Berlin, 14195

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53127

  • Novartis Investigative Site

    Chemnitz, Saxony, 09009

  • Novartis Investigative Site

    Coesfeld, North Rhine-Westphalia, 48653

  • Novartis Investigative Site

    Dresden, Saxony, 01219

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40217

  • Novartis Investigative Site

    Erlangen, Bavaria, 91054

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60596

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Goslar, Lower Saxony, 38642

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hamburg, 20259

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamburg, 22457

  • Novartis Investigative Site

    Hamburg, 22767

  • Novartis Investigative Site

    Heidelberg, Baden-Wurttemberg, 69115

  • Novartis Investigative Site

    Heidenheim, Baden-Wurttemberg, 89518

  • Novartis Investigative Site

    Ibbenbueren, North Rhine-Westphalia, 49477

  • Novartis Investigative Site

    Jena, Thuringia, 07743

  • Novartis Investigative Site

    Kiel, Schleswig-Holstein, 24103

  • Novartis Investigative Site

    Kiel, Schleswig-Holstein, 24105

  • Novartis Investigative Site

    Leer, Lower Saxony, 26789

  • Novartis Investigative Site

    Munich, Bavaria, 80335

  • Novartis Investigative Site

    Munich, Bavaria, 80637

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48149

  • Novartis Investigative Site

    Pinneberg, Schleswig-Holstein, 25421

  • Novartis Investigative Site

    Regensburg, Bavaria, 93049

  • Novartis Investigative Site

    Rehling, Bavaria, 86508

  • Novartis Investigative Site

    Rosenheim, Bavaria, 83002

  • Novartis Investigative Site

    Schwetzingen, Baden-Wurttemberg, 68723

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70174

  • Novartis Investigative Site

    Troisdorf, North Rhine-Westphalia, 53840

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89075

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65191

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199

Other trials in Germany

Spain19 sites

  • Novartis Investigative Site

    Alcala de Henares (Madrid)

  • Novartis Investigative Site

    Badalona, 08916

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Donostia / San Sebastian, 20014

  • Novartis Investigative Site

    Elche, 03203

  • Novartis Investigative Site

    Girona, 17007

  • Novartis Investigative Site

    Leganes, Madrid, 28911

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28035

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Móstoles, 28935

  • Novartis Investigative Site

    Oviedo, 33006

  • Novartis Investigative Site

    Palma de Mallorca, 07010

  • Novartis Investigative Site

    Valencia, 46010

  • Novartis Investigative Site

    Vigo ( Pontevedra), 36204

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Netherlands13 sites

  • Novartis Investigative Site

    Amersfoort, 3813 TZ

  • Novartis Investigative Site

    Delft, 2625 AD

  • Novartis Investigative Site

    Doetinchem, 7009 BL

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Heerlen, 6419 PC

  • Novartis Investigative Site

    Leidschendam, 2262 BA

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Nieuwegein, 3435 CM

  • Novartis Investigative Site

    Sittard-geleen, 6162 BG

  • Novartis Investigative Site

    The Hague, 2512 VA

  • Novartis Investigative Site

    The Hague, 2545 CH

  • Novartis Investigative Site

    Utrecht, 3582 KE

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Canada12 sites

  • Novartis Investigative Site

    Greater Sudbury, Ontario, P3E 5J1

  • Novartis Investigative Site

    London, Ontario, N6A 4L6

  • Novartis Investigative Site

    Mississauga, Ontario, L5B 1B8

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Toronto, Ontario, M6R 1B5

  • Novartis Investigative Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

United Kingdom10 sites

  • Novartis Investigative Site

    Birmingham, West Midlands, B18 7QH

  • Novartis Investigative Site

    Chelmsford, Essex, CM1 7ET

  • Novartis Investigative Site

    Huddersfield, HD3 3EA

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Manchester, Lancashire, M20 4BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

  • Novartis Investigative Site

    Sheffield, S10 2SJ

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

France9 sites

  • Novartis Investigative Site

    Angers, 49033

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Paris, 75248

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Toulouse Cedex9, 31059

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Ireland8 sites

  • Novartis Investigative Site

    Cork

  • Novartis Investigative Site

    Dooradoyle

  • Novartis Investigative Site

    Dublin, 4

  • Novartis Investigative Site

    Dublin, 8

  • Novartis Investigative Site

    Dublin, 9

  • Novartis Investigative Site

    Galway

  • Novartis Investigative Site

    Tallaght, Dublin, 24

  • Novartis Investigative Site

    Wilton, Cork

Other trials in Ireland

Italy8 sites

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40138

  • Novartis Investigative Site

    Crema, Lombardy, 26013

  • Novartis Investigative Site

    Genoa, Liguria, 16128

  • Novartis Investigative Site

    Genoa, Liguria, 16132

  • Novartis Investigative Site

    Milan, Lombardy, 20162

  • Novartis Investigative Site

    Parma, Emilia-Romagna, 43100

  • Novartis Investigative Site

    Rome, Lazio, 00133

  • Novartis Investigative Site

    Rome, Lazio, 00152

Other trials in Italy

Denmark7 sites

  • Novartis Investigative Site

    Aalborg, 9000

  • Novartis Investigative Site

    Hillerød, 3400

  • Novartis Investigative Site

    Koebenhavn Oe, 2100

  • Novartis Investigative Site

    Næstved, 4700

  • Novartis Investigative Site

    Odense C, 5000

  • Novartis Investigative Site

    Roskilde, 4000

  • Novartis Investigative Site

    Vejle, 7100

Other trials in Denmark

Hungary7 sites

  • Novartis Investigative Site

    Budapest, 1032

  • Novartis Investigative Site

    Budapest, 1088

  • Novartis Investigative Site

    Budapest, 1096

  • Novartis Investigative Site

    Kecskemét, 6000

  • Novartis Investigative Site

    Kistarcsa, 2143

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Tatabánya, 2800

Other trials in Hungary

Australia5 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Douglas, Queensland, 4814

  • Novartis Investigative Site

    Garran, Australian Capital Territory, 2606

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Redcliffe, Queensland, 4020

Other trials in Australia

Mexico5 sites

  • Novartis Investigative Site

    Acapulco de Juárez, Guerrero, 39670

  • Novartis Investigative Site

    Colima, 28010

  • Novartis Investigative Site

    Durango, 34000

  • Novartis Investigative Site

    Durango, 34079

  • Novartis Investigative Site

    Mexico City, 14050

Other trials in Mexico

Poland5 sites

  • Novartis Investigative Site

    Bydogoszcz, 85-796

  • Novartis Investigative Site

    Krakow, 31-115

  • Novartis Investigative Site

    Poznan, 61-866

  • Novartis Investigative Site

    Warsaw, 02-781

  • Novartis Investigative Site

    Wroclaw, 53-413

Other trials in Poland

Russia4 sites

  • Novartis Investigative Site

    Moscow, 107005

  • Novartis Investigative Site

    Moscow, 115 478

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

South Africa4 sites

  • Novartis Investigative Site

    Capital Park, 0002

  • Novartis Investigative Site

    Panorama, 7500

  • Novartis Investigative Site

    Parktown, 2193

  • Novartis Investigative Site

    Port Elizabeth, 6001

Other trials in South Africa

Tunisia4 sites

  • Novartis Investigative Site

    Sfax, 3000

  • Novartis Investigative Site

    Sousse, 4000

  • Novartis Investigative Site

    Tunis, 1004

  • Novartis Investigative Site

    Tunis, 1007

Other trials in Tunisia

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, 1425

  • Novartis Investigative Site

    Buenos Aires, C1405BWU

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1426ANZ

Other trials in Argentina

Bulgaria3 sites

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1756

Other trials in Bulgaria

Croatia3 sites

  • Novartis Investigative Site

    Osijek, 31000

  • Novartis Investigative Site

    Pula, 52100

  • Novartis Investigative Site

    Split, 21000

Other trials in Croatia

Czechia3 sites

  • Novartis Investigative Site

    Brno, 656 53

  • Novartis Investigative Site

    České Budějovice, 370 87

  • Novartis Investigative Site

    Prague, 180 00

Other trials in Czechia

Pakistan3 sites

  • Novartis Investigative Site

    Lahore, 54000

  • Novartis Investigative Site

    Lahore

  • Novartis Investigative Site

    Rawalpindi, 46000

Other trials in Pakistan

South Korea3 sites

  • Novartis Investigative Site

    Gyeonggi-do, 411-769

  • Novartis Investigative Site

    Seodaemun-gu, Seoul, 03722

  • Novartis Investigative Site

    Seoul, 135-710

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Istanbul, 34865

  • Novartis Investigative Site

    Istanbul

Other trials in Turkey (Türkiye)

Brazil2 sites

  • Novartis Investigative Site

    Rio de Janeiro, 20560-120

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41825-010

Other trials in Brazil

Chile2 sites

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 7500921

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 7591046

Other trials in Chile

Peru2 sites

  • Novartis Investigative Site

    Callao, Callao 2

  • Novartis Investigative Site

    Lima, Lima 34

Other trials in Peru

Colombia1 site

  • Novartis Investigative Site

    Bogotá

Other trials in Colombia

New Zealand1 site

  • Novartis Investigative Site

    Christchurch, 8001

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

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.

Read the 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).

Being tested
Lapatinib, Letrozole, Placebo
Keywords
Lapatinib, Letrozole, breast carcinoma, breast cancer, breast lump, HER2 positive metastatic breast cancer, breast cancer positive for human epidermal growth factor receptor 2, HER2, breast cancer progression, estrogen-receptor positive breast cancer, ER
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LapatinibDrug

    Also called GW572016

    1500 mg orally once a day

  • LetrozoleDrug

    2.5 mg orally once a day

  • PlaceboDrug

    Placebo (which matched with lapatinib tablet)

Study groups in NCT00073528
Study groupRoleWhat they receive
Placebo + Letrozole 2.5 mgPlacebo comparatorLetrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)
Receives: Drug: Letrozole; Drug: Placebo
Lapatinib 1500 mg + Letrozole 2.5 mgExperimentalLapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)
Receives: Drug: Lapatinib; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator

    PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

    Measured: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months

  2. Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator

    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months

Secondary outcomes (31)

  1. Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator

    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months

  2. PFS in Participants in the ITT Population as Assessed by the Investigator

    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months

  3. Overall Survival in the HER2-Positive Population

    Overall survival was defined as the time from randomization until death due to any cause.

    Measured: From date of randomization until date of death due to any cause, assessed up to 46 months

  4. Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator

    OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.

    Measured: Up to 46 months

  5. Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator

    Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.

    Measured: Up to 46 months

  6. Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator

    CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.

    Measured: Up to 46 months

  7. Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.

    CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.

    Measured: Up to 46 months

  8. Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.

    CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.

    Measured: Up to 46 months

  9. Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator

    Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.

    Measured: Up to 46 months

  10. Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator

    Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.

    Measured: Up to 46 months

  11. Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population

    The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.

    Measured: Up to 46 months

  12. Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator

    TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.

    Measured: Up to 46 months

  13. Overall Survival in the ITT Population

    Overall survival was defined as the time from randomization until death due to any cause.

    Measured: From date of randomization until date of death due to any cause, assessed up to 46 months

  14. Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator

    OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.

    Measured: Up to 46 months

  15. Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator

    Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.

    Measured: Up to 46 months

  16. Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator

    CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.

    Measured: Up to 46 months

  17. Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator

    Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.

    Measured: Up to 46 months

  18. Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator

    Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.

    Measured: Up to 46 months

  19. Number of Participants With Evidence of Brain Metastases From the ITT Population

    The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.

    Measured: Up to 46 months

  20. TTP for Participants From the ITT Population as Assessed by the Investigator

    TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.

    Measured: Up to 46 months

  21. Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits

    Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.

    Measured: Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit

  22. Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data

    Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.

    Measured: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit

  23. Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data

    FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.

    Measured: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit

  24. Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data

    The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.

    Measured: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit

  25. Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores

    A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.

    Measured: Up to 46 months

  26. Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status

    Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.

    Measured: Up to 46 months

  27. Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity

    IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.

    Measured: Up to 46 months

  28. Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower

    The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.

    Measured: Up to 46 months

  29. Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive

    Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.

    Measured: Up to 46 months

  30. Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive

    Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.

    Measured: Up to 46 months

  31. Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline

    EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2003 (estimated)
  2. Study start9 Dec 2003
  3. Primary completion3 Jun 2008
  4. Study completion22 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073528
Sponsor's protocol ID
EGF30008
Other IDs
CLAP016A2308, 2004-003928-35, 2004
Status last verified
Feb 2021
First submitted
24 Nov 2003
Last updated
24 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 19786658

  • 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.

    PubMed 20156908

  • 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.

    PubMed 20798196

  • 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.

    PubMed 24198242

  • 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.

    PubMed 27281556

  • 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.

    PubMed 29522361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib and Letrozole in people with Breast Neoplasms, run by Novartis Pharmaceuticals at 278 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 278 sites in United States, Germany, Spain, Netherlands, Canada and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator (time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00073528, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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