Phase 2
Completed N=108
Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms
Source: ClinicalTrials.gov NCT00062751 ↗Enrolled (actual)
108
Serious AEs
27.8%
Results posted
Nov 2010
Primary outcomePrimary: Percentage of Participants With Objective Response (OR)
Summary
To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
— | — |
| SECONDARY Percentage of Participants With Best Overall Response (Clinical Benefit) |
— | — |
| SECONDARY Time to Disease Progression |
— | — |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Percentage of Participants Exhibiting Freedom From Progression |
— | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Number of Participants With Survival |
— | — |
| SECONDARY Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score |
— | — |
| SECONDARY Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23 |
— | — |
| SECONDARY Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27 |
— | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) Sum |
— | — |
| SECONDARY 24-hour Trough Concentration (C Trough) |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00062751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.