A Phase 2 Randomized Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral Temsirolimus (CCI-779), Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer
18 Years
N/A
Female
Breast Neoplasms
Trial Information
A Phase 2 Randomized Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral Temsirolimus (CCI-779), Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer
Inclusion Criteria:
- Postmenopausal women with histologically confirmed, measurable locally advanced
disease or metastatic breast.
- Must be appropriate to receive endocrine therapy as treatment for advanced disease
(chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase
inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or
trastuzumab, are permitted).
- Women may either present with de novo advanced or metastatic cancer, or have had
tumor progression while receiving adjuvant tamoxifen or at any time after completing
adjuvant tamoxifen, or have had tumor progression while receiving first-line
metastatic therapy with tamoxifen.
Exclusion Criteria:
- Patients having known central nervous system (CNS) metastases.
- Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
- Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1
week prior to day 1 of treatment on study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Objective Response (OR)
Outcome Description:
OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.
Outcome Time Frame:
Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3066A1-204
NCT ID:
NCT00062751
Start Date:
December 2002
Completion Date:
October 2009
Related Keywords:
- Breast Neoplasms
- breast
- neoplasms
- Breast Neoplasms
- Neoplasms
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