Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: lapatinib; capecitabine
Intervention description: Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally.; Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Metastatic Breast Cancer; HER2 positive; HER2+; breast cancer; lapatinib; TYVERB; TYKERB; Capecitabine

Summary:

      Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib +
      capecitabine in women with Human epidermal growth factor receptor 2 (HER2) positive advanced
      or metastatic breast cancer.
    

Eligibility 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
             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;