A Phase 2 interventional study of Letrozole / Temsirolimus (CCI-779) and Letrozole / Temsirolimus (CCI-779) in Breast Neoplasms, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-15.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 2, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 108 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Letrozole / Temsirolimus (CCI-779)
Drug: Letrozole / Temsirolimus (CCI-779)
Drug: Letrozole
Drug page: Temsirolimus
Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
Drug page: Temsirolimus
Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
Also known as: Letrozole / Temsirolimus(CCI-779), Torisel
Letrozole 2.5 mg daily
Also known as: Letrozole alone
Percentage of Participants With Objective Response (OR)
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.
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
Percentage of Participants With Best Overall Response (Clinical Benefit)
Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease \[PD\]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.
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)
Time to Disease Progression
Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).
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)
Time to Treatment Failure
Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.
Time frame: Baseline until Progressive disease, death, or discontinuation of study treatment
Percentage of Participants Exhibiting Freedom From Progression
Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD \[at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions\]).
Time frame: Baseline, 8 weeks, 6 months, 12 months, and 24 months
Duration of Response
Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.
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)
Number of Participants With Survival
Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.
Time frame: Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death
Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.
Time frame: Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)
Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23
Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.
Time frame: Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)
Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27
Number of participants with antitumor response (CR \[disappearance of all target and non-target lesions with normalization of tumor marker level\] or PR \[at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD\]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.
Time frame: 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)
Area Under the Concentration-time Curve (AUC) Sum
Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr\*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).
Time frame: 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
24-hour Trough Concentration (C Trough)
C trough in whole blood measured as nanograms per milliliter (ng/mL).
Time frame: 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
| Milestone | Let 2.5 mg Plus 10 mg Daily CCI-779 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Let 2.5 mg Plus 25mg Daily CCI-779 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 |
|---|---|---|---|---|---|
| Started | 33 | 30 | 33 | 6 | 6 |
| Completed | 0 | 0 | 3 | 1 | 0 |
| Not completed | 33 | 30 | 30 | 5 | 6 |
| Withdrew: Disease progression | 24 | 17 | 24 | 2 | 2 |
| Withdrew: Adverse event | 4 | 7 | 2 | 2 | 2 |
| Withdrew: Other | 2 | 3 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 | 2 | 1 | 0 |
| Withdrew: Symptomatic deterioration | 1 | 1 | 0 | 0 | 1 |
| Withdrew: Death | 1 | 0 | 1 | 0 | 0 |
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.
No measurements were reported for this outcome.
Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease \[PD\]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.
No measurements were reported for this outcome.
Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).
No measurements were reported for this outcome.
Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.
No measurements were reported for this outcome.
Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD \[at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions\]).
No measurements were reported for this outcome.
Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.
No measurements were reported for this outcome.
Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.
No measurements were reported for this outcome.
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.
No measurements were reported for this outcome.
Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.
No measurements were reported for this outcome.
Number of participants with antitumor response (CR \[disappearance of all target and non-target lesions with normalization of tumor marker level\] or PR \[at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD\]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.
No measurements were reported for this outcome.
Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr\*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).
No measurements were reported for this outcome.
C trough in whole blood measured as nanograms per milliliter (ng/mL).
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Let 2.5 mg Plus 10 mg Daily CCI-779 | — | 12/33 (36.4%) | 33/33 (100%) |
| Let 2.5 mg Plus 30 mg Intermittent CCI-779 | — | 10/30 (33.3%) | 30/30 (100%) |
| Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779 | — | 9/33 (27.3%) | 32/33 (97%) |
| After Cross-over to 75 mg Intermittent CCI-779 | — | 1/18 (5.6%) | 16/18 (88.9%) |
| Let 2.5 mg Plus 25mg Daily CCI-779 | — | 2/6 (33.3%) | 6/6 (100%) |
| Let 2.5 mg Plus 75 mg Intermittent CCI-779 | — | 1/6 (16.7%) | 6/6 (100%) |
| Event | Let 2.5 mg Plus 10 mg Daily CCI-779 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779 | After Cross-over to 75 mg Intermittent CCI-779 | Let 2.5 mg Plus 25mg Daily CCI-779 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 |
|---|---|---|---|---|---|---|
| InfectionGeneral disorders | 0/33 | 1/30 | 0/33 | 0/18 | 0/6 | 1/6 |
| SepsisGeneral disorders | 1/33 | 0/30 | 0/33 | 0/18 | 0/6 | 1/6 |
| Septic shockGeneral disorders | 0/33 | 0/30 | 0/33 | 0/18 | 1/6 | 0/6 |
| MucositisGastrointestinal disorders | 0/33 | 0/30 | 0/33 | 0/18 | 1/6 | 1/6 |
| AnemiaBlood and lymphatic system disorders | 0/33 | 0/30 | 0/33 | 0/18 | 1/6 | 0/6 |
| Lung infiltration NOSRespiratory, thoracic and mediastinal disorders | 0/33 | 0/30 | 0/33 | 0/18 | 1/6 | 0/6 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/33 | 1/30 | 0/33 | 0/18 | 0/6 | 0/6 |
| CellulitisGeneral disorders | 2/33 | 0/30 | 0/33 | 0/18 | 0/6 | 0/6 |
| Spinal cord compressionNervous system disorders | 0/33 | 0/30 | 2/33 | 0/18 | 0/6 | 0/6 |
| DiarrheaGastrointestinal disorders | 0/33 | 1/30 | 1/33 | 1/18 | 0/6 | 0/6 |
| Event | Let 2.5 mg Plus 10 mg Daily CCI-779 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779 | After Cross-over to 75 mg Intermittent CCI-779 | Let 2.5 mg Plus 25mg Daily CCI-779 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 |
|---|---|---|---|---|---|---|
| AstheniaGeneral disorders | 15/33 | 21/30 | 20/33 | 10/18 | 5/6 | 6/6 |
| AnemiaBlood and lymphatic system disorders | 6/33 | 4/30 | 3/33 | 1/18 | 5/6 | 2/6 |
| DiarrheaGastrointestinal disorders | 13/33 | 15/30 | 6/33 | 9/18 | 4/6 | 2/6 |
| MucositisGastrointestinal disorders | 10/33 | 15/30 | 2/33 | 10/18 | 4/6 | 4/6 |
| StomatitisGastrointestinal disorders | 5/33 | 8/30 | 2/33 | 4/18 | 4/6 | 3/6 |
| Peripheral edemaMetabolism and nutrition disorders | 16/33 | 11/30 | 5/33 | 4/18 | 4/6 | 2/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/33 | 13/30 | 12/33 | 5/18 | 4/6 | 2/6 |
| RashSkin and subcutaneous tissue disorders | 7/33 | 13/30 | 6/33 | 7/18 | 4/6 | 2/6 |
| InfectionGeneral disorders | 9/33 | 8/30 | 9/33 | 1/18 | 3/6 | 2/6 |
| NauseaGastrointestinal disorders | 7/33 | 11/30 | 10/33 | 5/18 | 2/6 | 3/6 |
| Age Continuous(years) | Let 2.5 mg Plus 10 mg Daily CCI-779 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Let 2.5 mg Plus 25mg Daily CCI-779 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Total |
|---|---|---|---|---|---|---|
| Mean | 62.21 ± 11.87 | 62.83 ± 8.39 | 60.85 ± 9.79 | 61.83 ± 9.83 | 60.00 ± 9.65 | 61.82 ± 9.98 |
| Sex/Gender, Customized(participants) | Let 2.5 mg Plus 10 mg Daily CCI-779 | Let 2.5 mg Plus 30 mg Intermittent CCI-779 | Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779 | Let 2.5 mg Plus 25mg Daily CCI-779 | Let 2.5 mg Plus 75 mg Intermittent CCI-779 | Total |
|---|---|---|---|---|---|---|
| Female | 33 | 30 | 33 | 6 | 6 | 108 |
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Studies of the drug tested here: Temsirolimus
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