A

• Conditions: ADVANCED BREAST CANCER; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005637-38-IT
• Lead Sponsor: FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease. 2. ER positive tumor = 10% 3. HER2 negative breast cancer by FISH or IHC (IHC 0,1+, 2+ and/or FISH HER2: CEP17 ratio < 2.0,) 4. Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer 4. Paraffin-embedded tumor available for centralized assessment of biomarkers (either archived primary tumor tissue or biopsy of a metastatic site) 5. Measurable disease according to RECIST 1.1 or bone only disease (bone only disease is allowed if measurable or evaluable). Previously irradiated lesions are deemed measurable only if progression is documented at the site after completion of radiation. 6. Females, 18 years of age or older. 7. Postmenopausal status defined as: • Prior bilateral surgical oophorectomy; • Amenorrhea and age > 60 years; • Age <60 years and amenorrhea for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and estradiol in the postmenopausal ranges. 8. Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2 9. Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade >1 (except alopecia or other toxicities not considered a safety risk for the patient). 10. Adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Unstable brain metastases (stable brain metastases not requiring steroids are allowed); presence of spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. 2. Major surgery within 3 weeks of first study treatment. 3. Prior treatment with: • More than one line of chemotherapy for advanced breast cancer • More than two lines of endocrine treatment for advanced breast cancer • Any CDK inhibitor. 4. Current treatment with: • Any experimental treatment on another clinical trial; • Therapeutic doses of anticoagulant (Low dose anticoagulants for deep vein thrombosis prophylaxis are allowed. Aspirin is permitted.) 5. Current use or anticipated need for: • food or drugs that are known strong CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine • drugs that are known strong CYP3A4 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John’s Wort) 6. Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 7. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade =2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. 8. Active inflammatory bowel disease or chronic diarrhea. Short bowel syndrome. Upper gastrointestinal surgery including gastric resection. 9. Known hypersensitivity to letrozole, anastrazole, exemestane or fulvestrant, or to any of their excipients. 10. Known human immunodeficiency virus infection; active Hepatitis C, active hepatitis B 11. Severe medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with interpretation of study results and, in the investigator opinion, would make the subject inappropriate for this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified