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A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01160211
Recruitment Status : Active, not recruiting
First Posted : July 12, 2010
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: lapatinib Drug: trastuzumab Drug: Aromatase inhibitor Phase 3

Detailed Description:
This is a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first- or second-line therapy in postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies. Eligible subjects will be postmenopausal; have tumors that are ER and/or PgR positive and HER2-positive; have Stage IV metastatic breast cancer. The primary objective is to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.) trastuzumab/AI combination for progression free survival. The secondary objectives are to evaluate progression free survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI, overall survival, overall response rate, clinical benefit rate, the safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to baseline.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2+ Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies
Actual Study Start Date : May 5, 2011
Estimated Primary Completion Date : May 5, 2019
Estimated Study Completion Date : May 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lapatinib plus trastuzumab plus aromatase inhibitor
Experimental
Drug: lapatinib
1000 mg by mouth once a day
Drug: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
Active Comparator: trastuzmab plus aromatase inhibitor
Active Comparator
Drug: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
Active Comparator: lapatinib plus aromatase inhibitor
Active Comparator
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
Drug: lapatinib
1500 mg by mouth once daily



Primary Outcome Measures :
  1. Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination [ Time Frame: approximately 6 years ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) of trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI [ Time Frame: approximately 6 years ]
  2. Overall survival (OS) of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI [ Time Frame: approximately 6 years ]
  3. Overall response rate (complete or partial response), time to response, and duration of response in lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI [ Time Frame: approximately 6 years ]
  4. Clinical benefit (complete response, partial response, or stable disease for at least 6 months) of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI [ Time Frame: approximately 6 years ]
  5. Safety and tolerability of all three treatment groups (lapatinib/ trastuzumab/ AI, trastuzumab/ AI, or lapatinib/AI) [ Time Frame: approximately 6 years ]
  6. Changes in the quality of life (QoL) status relative to baseline of lapatinib/trastuzumab/AI vs. trastuzumab/AI and lapatinib/AI vs. trastuzumab/AI [ Time Frame: approximately 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:

  1. Signed written informed consent. In Korea and Japan, subjects who are between >=18 and <20 years of age must also have a legal representative sign the written informed consent.
  2. Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any of the following:

    • Subjects at least 60 years of age.
    • Subjects under 60 years of age and amenorrhic for at least 12 consecutive months AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility).
    • Prior bilateral oophorectomy.
    • Prior radiation castration with amenorrhea for at least 6 months
  3. Subjects must have a history of histologically confirmed breast cancer, with a clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  4. Tumors that are ER+ and/or PgR+ by local laboratory
  5. Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as:

    • 3+ by Immunohistochemistry (IHC) and/or
    • HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0]
  6. Subject must have received at least one prior regimen containing trastuzumab in combination with chemotherapy for breast cancer:.

    • Subject has ONLY received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment. OR
    • Subject has received ONE prior trastuzumab-containing regimen for metastatic disease (and has progressed), and may or may not have received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment.
  7. Subject must have received prior endocrine therapy (such as aromatase inhibitors or selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6 months as assessed by the treating investigator

9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) ≥50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE (Version 4.0) ≤ Grade 1 at the time of randomization 12. Completion of screening assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the following criteria:

  • QTc <450msec or
  • QTc <480msec for subjects with bundle branch block The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB) or to Fridericia's formula (QTcF), machine or manual over read, for males and females. The specific formula that will be used in a protocol should be determined prior to initiation of the study, and the formula used to determine inclusion and discontinuation should be the same throughout the study. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period

Exclusion criteria:

  1. History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  2. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening (subjects who are intended for chemotherapy)
  3. Serious cardiac illness or medical condition including but not confined to:

    • Uncontrolled arrhythmias
    • Uncontrolled or symptomatic angina
    • History of congestive heart failure (CHF)
    • Documented myocardial infarction <6 months from study entry
  4. Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  6. Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
  7. Have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
  8. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients that, in the opinion of the Investigator or GSK medical monitor, contraindicates their participation
  9. Any prohibited medication.
  10. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160211


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United States, California
Novartis Investigative Site
La Jolla, California, United States, 92093-0987
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Pleasant Hill, California, United States, 94523
United States, Florida
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33145
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Augusta, Georgia, United States, 30912
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Lawrenceville, Georgia, United States, 30046
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Chicago, Illinois, United States, 60611-2906
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Goshen, Indiana, United States, 46526
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Waterloo, Iowa, United States, 52132
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Grand Rapids, Michigan, United States, 49503
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Minneapolis, Minnesota, United States, 55407-3799
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Billings, Montana, United States, 59102
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Omaha, Nebraska, United States, 68114
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Albuquerque, New Mexico, United States, 87106
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Albuquerque, New Mexico, United States, 87110
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Cary, North Carolina, United States, 27518
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Dayton, Ohio, United States, 45420
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Germantown, Tennessee, United States, 38138
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Houston, Texas, United States, 77030
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Tacoma, Washington, United States, 98405
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Milwaukee, Wisconsin, United States, 53226
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Berazategui, Buenos Aires, Argentina, B1880BBF
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Capital Federal, Buenos Aires, Argentina, C1417DTN
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Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina, C1050AAK
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
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La Plata, Buenos Aires, Argentina, B1920CMK
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Viedma, Río Negro, Argentina, R8500ACE
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Rosario, Santa Fe, Argentina, S2000KZE
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Ciudad Autonoma de Buenos Aires, Argentina, C1025ABH
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Cordoba, Argentina, X5004FHP
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La Rioja, Argentina, F5300COE
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Quilmes, Argentina, 1878
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San Miguel de Tucuman, Argentina, T4000IAK
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Box Hill, Victoria, Australia, 3128
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Wodonga, Victoria, Australia, 3690
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Adelaide, Australia, 5000
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Douglas, Australia, 4814
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Ringwood East, Australia, 3135
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Tweed Heads, Australia, 2485
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Namur, Belgium, 5000
Brazil
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Fortaleza, Ceará, Brazil, 60430-230
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Goiania, Goiás, Brazil, 74605-070
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Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
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Barretos, São Paulo, Brazil, 14784-400
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Sao Paulo, São Paulo, Brazil, 01317-001
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Sao Paulo, São Paulo, Brazil, 01323-903
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Sao Paulo, São Paulo, Brazil, 03102-002
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Sao Paulo, São Paulo, Brazil, 05651-901
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Rio de Janeiro, Brazil, 20560-120
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Plovdiv, Bulgaria, 4004
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Sofia, Bulgaria, 1756
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Sofia, Bulgaria, 1784
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Varna, Bulgaria, 9010
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Calgary, Alberta, Canada, T2N 4N2
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Fuzhou, Fujian, China, 350001
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Guangzhou, Guangdong, China, 510060
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Changchun, Jilin, China, 130021
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Harbin, China, 150081
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Shanghai, China, 200032
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Monteria, Colombia
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Osijek, Croatia, 31000
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Pula, Croatia, 52100
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Zagreb, Croatia, 10000
France
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Besancon, France, 25030
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Le Mans, France, 72000
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Lille, France, 59000
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Montpellier Cedex 5, France, 34298
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Nancy, France, 54100
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Paris Cedex 20, France, 75970
Germany
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Heidelberg, Baden-Wuerttemberg, Germany, 69115
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
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Muenchen, Bayern, Germany, 80335
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Muenchen, Bayern, Germany, 81675
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Fuerstenwalde, Brandenburg, Germany, 15517
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Rostock, Mecklenburg-Vorpommern, Germany, 18059
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Goslar, Niedersachsen, Germany, 38642
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Hannover, Niedersachsen, Germany, 30559
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Aachen, Nordrhein-Westfalen, Germany, 52066
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Bottrop, Nordrhein-Westfalen, Germany, 46236
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Troisdorf, Nordrhein-Westfalen, Germany, 53840
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Velbert, Nordrhein-Westfalen, Germany, 42551
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Halle, Sachsen-Anhalt, Germany, 06120
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Kiel, Schleswig-Holstein, Germany, 24103
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Berlin, Germany, 10317
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Berlin, Germany, 12200
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Hamburg, Germany, 22081
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Athens, Greece, 115 28
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Chania, Greece, 73100
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Heraklion, Greece, 71110
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Perioxi Dragana, Alexandroupolis, Greece, 68100
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Hungary
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Budapest, Hungary, 1032
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Debrecen, Hungary, H-4032
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Gyor, Hungary, H-9024
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Gyula, Hungary, 5700
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Kaposvar, Hungary, 7400
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Miskolc, Hungary, 3526
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Nyiregyhaza, Hungary, 4400
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Pecs, Hungary, 7624
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Szeged, Hungary, 6720
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Szolnok, Hungary, 5004
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Veszprem, Hungary, 8200
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Zalaegerszeg, Hungary, H-8900
India
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Bangalore, India, 560052
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Chennai, India, 600116
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Delhi, India, 110085
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Nagpur, India, 440010
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New Delhi, India, 110 092
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Pune, India, 411001
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Surat, India, Saroli - 394601Dist - Surat
Ireland
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Dublin 7, Ireland
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Dublin, Ireland, 4
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Dublin, Ireland, 7
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Dublin, Ireland, 8
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Galway, Ireland
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Petah-Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 69710
Italy
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Parma, Emilia-Romagna, Italy, 43100
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Piacenza, Emilia-Romagna, Italy, 29100
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Monza, Lombardia, Italy, 20052
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Pavia, Lombardia, Italy, 27100
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Rozzano (MI), Lombardia, Italy, 20089
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San Giovanni Rotondo, Italy, 71013
Japan
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Aichi, Japan, 464-8681
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Chiba, Japan, 277-8577
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Ehime, Japan, 791-0280
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Kagoshima, Japan, 892-0833
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Osaka, Japan, 540-0006
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Osaka, Japan, 565-0871
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Saitama, Japan, 350-1298
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Saitama, Japan, 362-0806
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Shizuoka, Japan, 411-8777
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Tokyo, Japan, 104-8560
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Tokyo, Japan, 113-8677
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Tokyo, Japan, 142-8666
Korea, Republic of
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Gyeonggi-do, Korea, Republic of, 410-769
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 138-736
Lithuania
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Vilnius, Lithuania, LT-08660
Mexico
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Toluca, Estado de México, Mexico, 50080
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Mexico, Mexico, 06760
Norway
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Lorenskog, Norway
Peru
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Miraflores, Lima, Peru, Lima 18
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San Borja, Lima, Peru, Lima 41
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San Isidro, Lima, Peru, Lima 27
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Arequipa, Peru
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Lima, Peru, Lima 18
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Trujillo, Peru, 44
Philippines
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Makati City, Philippines, 1218
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Quezon City, Philippines, 1102
Poland
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Gdansk, Poland, 80-952
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Konin, Poland, 62-500
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Lubin, Poland, 59-301
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Olsztyn, Poland, 10-513
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Otwock, Poland, 05-400
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Warszawa, Poland, 02-776
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Warszawa, Poland, 04-125
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Wieliszew, Poland, 05-135
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Wroclaw, Poland, 53-413
Portugal
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Coimbra, Portugal, 3000-075
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Evora, Portugal, 7000-811
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Lisboa, Portugal, 1649-035
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Lisbon, Portugal, 1400-038
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Porto, Portugal, 4200-072
Puerto Rico
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San Juan, Puerto Rico, 00910
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San Juan, Puerto Rico, 00935
Romania
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Bucharest, Romania, 050098
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Bucuresti, Romania, 022328
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Timisoara, Romania, 300239
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 117997
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Ryazan, Russian Federation, 390011
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 197758
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Tver, Russian Federation, 170008
Serbia
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Sremska Kamenica, Serbia, 21204
Singapore
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Singapore, Singapore, 308433
South Africa
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Amanzimtoti, South Africa, 4126
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Cape Town, South Africa, 7700
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Durban, South Africa, 4091
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Port Elizabeth, South Africa, 6045
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Pretoria, South Africa, 0081
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Saxonwold, Johannesburg, South Africa, 2196
Spain
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Barcelona, Spain, 08025
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Barcelona, Spain, 08036
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Castellon, Spain, 12002
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Cordoba, Spain, 14004
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La Coruna, Spain, 15009
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Madrid, Spain, 28040
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Santa Cruz de Tenerife, Spain, 38320
Taiwan
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Changhua, Taiwan, 500
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Kaohsiung Hsien, Taiwan, 833
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Taipei City, Taiwan, 11217
Turkey
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Ankara, Turkey
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Izmir, Turkey, 35100
Ukraine
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Chernivtsi, Ukraine, 58013
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Dnipropetrovsk, Ukraine, 49102
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Kharkiv, Ukraine, 61070
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Khmelnytskyi, Ukraine, 29000
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Lyutizh, Ukraine, 07352
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Sumy, Ukraine, 40005
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Uzhgorod, Ukraine, 88000
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Vinnitsia, Ukraine, 21029
United Kingdom
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Chelmsford, Essex, United Kingdom, CM1 7ET
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Birmingham, West Midlands, United Kingdom, B18 7QH
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Huddersfield, United Kingdom, HD3 3EA
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London, United Kingdom, NW3 2QG
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London, United Kingdom, SW3 6JJ
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Maidstone, United Kingdom, ME16 9QQ
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Manchester, United Kingdom, M20 4BX
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Nottingham, United Kingdom, NG5 1PB
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Peterborough, United Kingdom, PE3 9GZ
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Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Novartis Pharmaceuticals
GlaxoSmithKline
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01160211     History of Changes
Other Study ID Numbers: 114299
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
1st line MBC
MBC
hormone receptor positive
lapatinib
trastuzumab
HER2 positive
aromatase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Lapatinib
Trastuzumab
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists