Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00508274
First received: July 26, 2007
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib + capecitabine in women with HER positive advanced or metastatic breast cancer. Primary objective is response rate.


Condition Intervention Phase
Neoplasms, Breast
Drug: lapatinib in combination with capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Study Administering Lapatinib and Capecitabine in Women With Advanced or MEtastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Clinical Benefit Rate (CBR) [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.

  • Six Months Progression-Free Survival [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.

  • Time to Response [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    Time to response is defined as the time from first dose date until first documentation of disease response.

  • Duration of Response [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.

  • Central Nervous System as First Site of Relapse [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]
    Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.


Enrollment: 52
Study Start Date: July 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lapatinib in combination with capecitabine
daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)
Drug: lapatinib in combination with capecitabine
daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent;
  • Female ≥18 years;
  • Pathology that has histologically confirmed invasive breast cancer with stage IIIb/c or stage IV disease;

    • If recurrent disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.

  • Documented overexpression of Her2(ErbB2) of IHC 3+ or FISH positive, in primary or metastatic tumor tissue is required for enrollment into the study; by local testing or central laboratory testing determined by country of residence. NB. Approximately, 51 subjects will be enrolled in a single stage design to test for efficacy in women from China and Hong Kong. Due to the fact that trastuzumab is not commonly prescribed in China and Hong Kong, the current study allows up to 40% of subjects who are trastuzumab naïve to be enrolled.
  • Prior therapies must include at minimum a taxane and/or anthracycline and may include trastuzumab if available; other prior regimens are not limited except capecitabine and ErbB1/Erbb2 inhibitors other than trastuzumab. Chemo regimen requirements are as follows:

    • Taxane containing regimen for at least 4 cycles or <4 cycles provided disease progression or treatment limiting toxicity occurred while on taxane
    • Anthracycline containing regimen for at least 4 cycles or <4 cycles provided disease progression or treatment limiting toxicity occurred while on anthracycline
    • Taxanes and Anthracyclines may have been administered concurrently or separately
    • Prior treatment may have contained trastuzumab alone or in combination with other chemotherapy in the adjuvant, locally advanced or metastatic setting and patient must have failed the treatment
    • Prior treatment with capecitabine is not permitted unless 6 months have elapsed since the last dose of capecitabine and the subject is free of any capecitabine related toxicity
    • Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab is not permitted
    • Other prior chemo-regimens not listed above are unlimited.
  • For those subjects whose disease is ER+ and/or PR+ one of following criteria should be met.

    • Subjects 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
    • Subjects with visceral disease that requires chemotherapy (eg., subjects with liver or lung metastases)
    • Rapidly progressing or life threatening disease, as determined by the investigator
  • Subjects with stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible
  • 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;
  • 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;
  • Women 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 by the Table of 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.;
  • 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;
  • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508274

Locations
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510060
GSK Investigational Site
Guangzhou, Guangdong, China, 510515
China, Hubei
GSK Investigational Site
Wuhan, Hubei, China, 430030
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210009
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310006
GSK Investigational Site
Hangzhou, Zhejiang, China, 310022
China
GSK Investigational Site
Beijing, China, 100071
GSK Investigational Site
Beijing, China, 100021
GSK Investigational Site
Shanghai, China, 200032
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00508274     History of Changes
Other Study ID Numbers: EGF109491
Study First Received: July 26, 2007
Results First Received: July 24, 2009
Last Updated: January 16, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Advanced Metastatic Breast Cancer
breast cancer
lapatinib
HER2+ positive
TYVERB
TYKERB

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014