locally advanced or metastatic breast cancer (stage 3B or 4)
Conditions
Interventions
Product Name: Temsirolimus
Product Code: CCI-779 10mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pending
CAS Number: 162635-04-3
Current Sponsor code: CCI-779
Other descriptive name: Temsirolim
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged >18 years. 2. Postmenopausal subjects, defined by at least one of the following: - >= 60 years of age - 12 months prior to day 1 - 60 % (corresponds to Eastern Cooperative Oncology Group [ECOG] performance status 0 to 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Extensive visceral disease including bilateral diffuse lymphangitic involvement of the lung with more than 50% lung involvement, evidence of symptomatic central nervous system (CNS) metastases, extensive hepatic involvement defined as involvement of more than one third of the liver confirmed by sonogram and/or CT scan 2. Subjects with bone as the only site of disease. 3. Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion. 4. History of inflammatory breast cancer (IBC). 5. More than 1 regimen of chemotherapy (including antibody and/or cytotoxic therapy) in the metastatic setting. Subjects may have received prior adjuvant or neoadjuvant chemotherapy. 6. Chemotherapy or immunosuppressive agents <=2 weeks prior to day 1 of treatment on study, with the exception of systemic corticosteroids administered for physiologic replacement, or as an antiemetic after discussion with the medical monitor. 7. Hormonal treatment (including aromatase inhibitors) in the metastatic setting with the exception of prior short-term (< 14 days consecutive) use. 8. Adjuvant trastuzumab (Herceptin) or tamoxifen <= 2 weeks prior to day 1 of treatment on study. 9. Aromatase inhibitors as adjuvant therapy <= 12 months prior to day 1 of treatment on study. 10. Disease refractory (i.e., PD within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy. 11. Major surgery, biological therapy, immunologic therapy or local radiotherapy (subjects must not have had prior cumulative radiotherapy to more than 25% of the marrow) <= 2 weeks prior to day 1 of treatment on study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of overall progression free survival (PFS);Secondary Objective: Assessment of PFS at 12 and 24 months; Time to treatment failure; Time to progression; Overall response rate; Clinical benefit (CR+PR+ SD > 8 wks/24 wks); Duration of response; Time to initiation of subsequent anticancer therapy; Survival; Safety; Health outcomes; Prognostic markers and pharmacogenomics analysis ;Primary end point(s): Overall progression free survival is the primary endpoint of the study, and the clinical activity evaluation will be made using the RECIST guidelines. Non-target lesions, including bone disease, will only be assessed for CR, incomplete response/SD, and PD. | — |
Countries
Latvia, Lithuania, Slovakia, United Kingdom
Outcome results
None listed