Clinical trial NCT00062751: Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast
neoplasms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2003-06-13
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response (Clinical Benefit)
timeFrame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)
measure: Time to Disease Progression
timeFrame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)
measure: Time to Treatment Failure
timeFrame: Baseline until Progressive disease, death, or discontinuation of study treatment
measure: Percentage of Participants Exhibiting Freedom From Progression
timeFrame: Baseline, 8 weeks, 6 months, 12 months, and 24 months
measure: Duration of Response
timeFrame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)
measure: Number of Participants With Survival
timeFrame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death
measure: Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score
timeFrame: Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)
measure: Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23
timeFrame: Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)
measure: Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27
timeFrame: Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment)
measure: Area Under the Concentration-time Curve (AUC) Sum
timeFrame: Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12
measure: 24-hour Trough Concentration (C Trough)
timeFrame: Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: