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Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00062751
Pfizer
Completed
Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

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Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Letrozole / Temsirolimus (CCI-779)
    Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
  • Drug: Letrozole / Temsirolimus (CCI-779)
    Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
    Other Name: Letrozole / Temsirolimus(CCI-779), Torisel
  • Drug: Letrozole
    Letrozole 2.5 mg daily
    Other Name: Letrozole alone
  • Experimental: A
    Intervention: Drug: Letrozole / Temsirolimus (CCI-779)
  • Experimental: B
    Intervention: Drug: Letrozole / Temsirolimus (CCI-779)
  • Active Comparator: C
    Intervention: Drug: Letrozole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
October 2009
April 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00062751
3066A1-204
B1771005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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