Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer

ClinicalTrials.gov Identifier: NCT00281658

Novartis Reference Number: EGF104535

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a Phase III study designed to evaluate the response (shrinkage or lack of growth) of tumors of lapatinib plus paclitaxel compared to paclitaxel plus placebo as first line metastatic treatment in women and men who have metastatic breast cancer. Patients will be evaluated for safety and efficacy. Countries include China, Hong Kong, Thailand, Brazil and Peru.

Condition 
Neoplasms, Breast
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
443 participants
Start date 
Jan 02, 2006
Completion date 
Dec 31, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
lapatinib (GW572016) oral tablets
1500 mg oral daily continuously
Drug
paclitaxel infusion
Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months

Eligibility Criteria

Inclusion criteria:

Signed informed consent;
Male or female ≥18 years;
Histologically confirmed invasive breast cancer with stage IV disease; If the disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.
Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue by the central laboratory for randomization into the study;
If a taxane was administered in the neoadjuvant or adjuvant setting, progression must have occurred >12 months after completion of this treatment and the patient recovered from all associated toxicities;
Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors);
Radiotherapy as palliative treatment for painful metastatic disease is permitted but must have been stopped within 2 weeks prior to initiation of any investigational treatment. All subjects must have recovered from all radiotherapy related toxicities prior to initiation of any investigational treatment. The site of radiotherapy must not be used as a site of measurable disease;
Bisphosphonate therapy for bone metastases and is allowed; however, treatment must be initiated prior to the first dose of investigational treatment. Prophylactic use of bisphosphonates in subjects without bone disease is not permitted, except for the treatment of osteoporosis;
For those patients whose disease is ER+ and/or PR+ the following criteria should be met:

Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases) Rapidly progressing or life threatening disease, as determined by the investigator Patients who received hormonal therapy and are no longer benefiting from this therapy and the hormonal treatment must have been stopped before the first dose of investigational treatment;

Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive;
ECOG Performance Status of 0 to 1;
Life expectancy of ≥ 12 weeks;
Able to swallow and retain oral medication;
Archived tumor tissue available for testing;
Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study;
Willing to complete all screening assessments as outlined in the protocol;
Adequate organ function as defined in Table 1 Baseline Laboratory Values;

Exclusion Criteria:

Pregnant or lactating females at anytime during the study
Subjects with only non-measurable metastatic sites of disease per RECIST, (e.g. bone metastases, pleural effusion, or ascites, etc. (Refer to Section 5.3 Efficacy for list sites considered to be non-measurable disease.);
Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for metastatic disease.
Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab in the adjuvant setting. If trastuzumab was administered in the adjuvant setting, then > 12 months must have elapsed since completion of trastuzumab therapy;
Planned concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment;
Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
Peripheral neuropathy of Grade 2 or greater;
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
History of other malignancy. However, 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;
Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;
Uncontrolled infection;
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
Known history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis;
Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines;
Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents;
Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational treatment;
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel or lapatinib or their excipients.

Study Locations

Brazil
Novartis Investigative Site
-
Salvador, 40.050-410
Bahía
Brazil
Novartis Investigative Site
-
Salvador, 40285-001
Bahía
Brazil
Novartis Investigative Site
-
Belo Horizonte, 30150-281
Minas Gerais
Brazil
Novartis Investigative Site
-
Porto Alegre, 90610 000
Rio Grande Do Sul
Brazil
Novartis Investigative Site
-
Natal, 59075-740
Rio Grande Du Norte
Brazil
Novartis Investigative Site
-
Jau, 17210-120
São Paulo
Brazil
Novartis Investigative Site
-
Santo Andre, 09060-650
São Paulo
Brazil
Novartis Investigative Site
-
Sao Paulo, 01221-020
São Paulo
Brazil
Novartis Investigative Site
-
Sao Paulo, 03102-002
São Paulo
Brazil
China
Novartis Investigative Site
-
Guangzhou, 510060
Guangdong
China
Novartis Investigative Site
-
Wuhan, 430030
Hubei
China
Novartis Investigative Site
-
Nanjing, 210002
Jiangsu
China
Novartis Investigative Site
-
Nanjing, 210009
Jiangsu
China
Novartis Investigative Site
-
Dalian, 116027
Liaoning
China
Novartis Investigative Site
-
Xi'an, 710032
Shaanxi
China
Novartis Investigative Site
-
Xi'an, 710061
Shaanxi
China
Novartis Investigative Site
-
Jinan, 250012
Shandong
China
Novartis Investigative Site
-
Jinan, 250031
Shandong
China
Novartis Investigative Site
-
Jinan, 250117
Shandong
China
Novartis Investigative Site
-
Hangzhou, 310022
Zhejiang
China
Novartis Investigative Site
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Beijing, 100021
-
China
Novartis Investigative Site
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Beijing, 100036
-
China
Novartis Investigative Site
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Beijing, 100071
-
China
Novartis Investigative Site
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Beijing, 100853
-
China
Novartis Investigative Site
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Chengdu, 610041
-
China
Novartis Investigative Site
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Chongqing, 400037
-
China
Novartis Investigative Site
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Dalian, 116011
-
China
Novartis Investigative Site
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Fuzhou, 350001
-
China
Novartis Investigative Site
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Fuzhou, 350014
-
China
Novartis Investigative Site
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Shanghai, 200032
-
China
Novartis Investigative Site
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Shanghai, 200070
-
China
Novartis Investigative Site
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Shanghai, 200433
-
China
Novartis Investigative Site
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Shenyang, 110015
-
China
Novartis Investigative Site
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Tianjin, 300060
-
China
Hong Kong
Novartis Investigative Site
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Kowloon,
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Hong Kong
Novartis Investigative Site
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Pokfulam,
-
Hong Kong
Novartis Investigative Site
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Tuen Mun,
-
Hong Kong
Pakistan
Novartis Investigative Site
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Lahore, 53400
-
Pakistan
Novartis Investigative Site
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Lahore, 54600
-
Pakistan
Novartis Investigative Site
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Lahore,
-
Pakistan
Peru
Novartis Investigative Site
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Lima, Lima 34
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Peru
Russian Federation
Novartis Investigative Site
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Kazan, 420029
-
Russian Federation
Novartis Investigative Site
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Moscow, 117997
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Russian Federation
Novartis Investigative Site
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Moscow, 125101
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Russian Federation
Novartis Investigative Site
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Moscow, 143423
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Russian Federation
Novartis Investigative Site
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Rostov-na-Donu, 344037
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Russian Federation
Novartis Investigative Site
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Samara, 443031
-
Russian Federation
Novartis Investigative Site
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Voronezh, 394062
-
Russian Federation
Thailand
Novartis Investigative Site
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Bangkok, 10400
-
Thailand
Novartis Investigative Site
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Chiangmai, 50200
-
Thailand
Ukraine
Novartis Investigative Site
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Cherkasy, 18009
-
Ukraine
Novartis Investigative Site
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Chernihiv, 14029
-
Ukraine
Novartis Investigative Site
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Dnipropetrovsk, 49055
-
Ukraine
Novartis Investigative Site
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Zaporizhzhia, 69040
-
Ukraine

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