PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED WITH PLACEBO CLINICAL STUDY THAT COMPARES GW572016 AND LETROZOLE VERSUS LETROZOLE IN PATIENTS WITH BREAST CANCER OF METASTATIC OR ADVANCED FOR THE RECEPTOR OF ESTROGEN / PROGESTERONE
- Conditions
- -C509 Breast, unspecifiedBreast, unspecifiedC509
- Registration Number
- PER-064-04
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 36
• The participants signed the informed consent;
• Participants must have histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or relapse after surgery with curative intent [Singletary, 2002];
• The tumors of the participant are ER + and / or PgR +;
• Participants will be considered ER + or PgR + if any test (cytochemical, immunochemical, immunohistochemical [IHC] or radioimmunoassay) of primary or secondary tumor tissue is positive;
• Participants must be postmenopausal women> 18 years of age; The participants are at least 60 years old; The participants are under 60 years of age and have been amenorrheic for a minimum of 12 months, and / or have follicle stimulating hormone (FSH) values> 40 IU / 1;
• The participants have a Performance Status of 0 or 1 according to the ECOG;
• Participants should have archival tumor tissue available to compare the tumor response with the intratumoral expression of ErbBl and ErbB2. The tumor tissue of the file will also be used to confirm the positivity of the estrogen receptor (ER) and / or progesterone receptor (PgR). The results will not be used to determine the eligibility of the study participant;
• Adjuvant therapy with an aromatase inhibitor is allowed; however, treatment must have ended more than 1 year before (> 12 months) of the first dose of randomized therapy;
• Adjuvant therapy with trastuzumab is allowed; however, treatment must have ended more than 1 year before (> 12 months) of the first dose of randomized therapy;
• Participants who received neoadjuvant / adjuvant therapy now have a new relapse of advanced or metastatic disease are eligible; however, it is not required to have received a previous neoadjuvant / adjuvant therapy to enter the study;
• Participants must have completed a hormone replacement therapy (HRT) (for example: conjugated estrogen tablets, USP, [Premarin]), at least 1 month (30 days) before receiving the first dose of randomized therapy;
• Radiation therapy before the start of randomized therapy is allowed in a limited area (for example: palliative treatment for painful bone metastasis), if it is not the only place of the disease. The participant must have completed the treatment and recovered from all the toxicities related to the treatment, in particular, the suppression of the bone marrow;
• Participants can ingest and retain medications administered orally;
• Participants must have a fraction of cardiac output within the normal institutional range, according to the measurement made by echocardiogram (or MUGA examination, if an echocardiogram can not be performed or if it is inconclusive);
• Participants must undergo all the evaluations of the selection, as indicated in the protocol;
• The participants must have an adequate organic function
• • The participant is premenopausal, is pregnant or is breastfeeding;
• The participant previously received chemotherapy, hormonal therapy, immunotherapy, biological therapy or anti-ErbBl / ErbB2 therapy for advanced or metastatic disease
• Bisphosphonate therapy against bone metastasis is allowed; however, treatment must be started before the first dose of randomized therapy. The prophylactic use of bisphosphonates in bone disease participants, except for the treatment of osteoporosis, is not allowed;
• The participant suffers from malabsorption syndrome, a disease that significantly affects gastrointestinal function, or underwent a resection of the stomach or small intestine. Participants with ulcerative colitis are also excluded;
• The participant has a history of another malignancy. Participants who have not had the disease for 5 years, or participants with a history of completely resected nonmelanomatous skin cancer or successfully treated in situ carcinoma are eligible;
• Concurrent illnesses or conditions that would make the participant ineligible to participate in the study, or any medical disorder that could interfere with the participant´s safety;
• The participant has not recovered from toxicities related to previous adjuvant therapy (for example: surgery, radiotherapy, chemotherapy, hormonal therapy, immunotherapy, biological therapy and investigational agents);
• The participant received anthracyclines in the neoadjuvant and / or adjuvant environment that exceeded the following doses: 360 mg / m2 of Doxorubicin, 720 mg / m2 of Epirubicin and
• 72 mg / m2 of Mitoxantrone;
• The participant suffers from an extensive symptomatic visceral disease that includes hepatic involvement and pulmonary lymphangitic carcinomatosis, or the investigator considers that the disease is progressing rapidly or is potentially life-threatening;
• The participant suffers from an active or uncontrolled infection;
• The participant suffers from dementia, altered mental status or any psychiatric condition that would prevent her from understanding or providing informed consent;
• The participant has a known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure;
• The participant has a known history or clinical evidence of leptomeningeal carcinomatosis or central nervous system (CNS) metastasis;
• The participant is receiving concurrent therapy against cancer (chemotherapy, radiotherapy, surgery, immunotherapy, hormone therapy, targeted therapy, biological therapy or tumor embolization) different from letrozole;
• The participant is receiving concurrent treatment with an agent in research or is participating in another clinical trial;
• The participant has used an investigational medication within 30 days or 5 half-lives, whichever is longer, before the first dose of randomized therapy (GW572016 or placebo);
• The participant has had an immediate or delayed known hypersensitivity reaction, or idiosyncrasy to drugs chemically related to randomized therapy (GW572016 or placebo) or to the excipients of randomized therapy (GW572016 or placebo);
• The participant has hypersensitivity to Femara or to the excipients of Femara
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:It is defined as the time from randomization to the first date of disease progression or death due to any cause, if it occurred before.<br>Measure:Survival without progression<br>Timepoints:date of the progression of the radiological or symptomatic disease<br>
- Secondary Outcome Measures
Name Time Method