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Breast NeoplasmsPhase 3NCT00083993

Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

A Phase 3 study testing Temsirolimus (CCI-779) for 34 months and Letrozole for 34 months in people with Breast Neoplasms and Neoplasm Metastasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 129 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Neoplasm Metastasis
What is being tested?
Temsirolimus (CCI-779) for 34 months and Letrozole for 34 months
How many people
1,236 participants
Where
129 sitesin 2 countries
Study dates
May 2004to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged greater than 18 years.
  • Postmenopausal subjects
  • Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)

Who cannot join

  • Extensive visceral disease
  • Subjects with bone as the only site of disease
  • Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Trial locations and contacts

129 sites in 2 countries.

129 sites in 2 countries

United States112 sites

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Arlington, Texas, 76012

  • Study site

    Arlington, Virginia, 22205-3637

  • Study site

    Atlanta, Georgia, 30309-1710

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21231

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Belleville, New Jersey, 07109

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Binghamton, New York, 13905

  • Study site

    Bismarck, North Dakota, 58504

  • Study site

    Boca Raton, Florida, 33428

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Boston, Massachusetts, 02135

  • Study site

    Burbank, California, 91505

  • Study site

    Campbell, California, 95008

  • Study site

    Canton, Ohio, 44710

  • Study site

    Canton, Ohio, 44718

  • Study site

    Carson City, Nevada, 89703

  • Study site

    Centralia, Illinois, 62801

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45238

  • Study site

    Cleveland, Ohio, 44106-5055

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Columbia, South Carolina, 29169

  • Study site

    Columbus, Georgia, 31902

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Corpus Christi, Texas, 78412

  • Study site

    Corvallis, Oregon, 97330

  • Study site

    Dallas, Texas, 75230

  • Study site

    Detroit, Michigan, 48202

  • Study site

    East Syracuse, New York, 13057

  • Study site

    Flint, Michigan, 48503

  • Study site

    Fort Lauderdale, Florida, 33305

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Frederick, Maryland, 21701

  • Study site

    Gastonia, North Carolina, 28054

  • Study site

    Gilroy, California, 95020

  • Study site

    Glendora, California, 91740

  • Study site

    Grand Rapids, Michigan, 49503

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Great Falls, Montana, 59406

  • Study site

    Harrisburg, Pennsylvania, 17110

  • Study site

    Hattiesburg, Mississippi, 39401

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Hoover, Alabama, 35216

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Irving, Texas, 75038

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Lakewood, Colorado, 80215

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Logan, Utah, 84341

  • Study site

    Mayfield Heights, Ohio, 44124

  • Study site

    Miami Shores, Florida, 33138

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Modesto, California, 95355

  • Study site

    Montebello, California, 90640

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Munster, Indiana, 46321

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New York, New York, 10032

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Nyack, New York, 10960

  • Study site

    Ogden, Utah, 84403

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plantation, Florida, 33324

  • Study site

    Pomona, California, 91767

  • Study site

    Portland, Oregon, 97213

  • Study site

    Poway, California, 92064

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rolla, Missouri, 65401

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Sacramento, California, 95816

  • Study site

    San Diego, California, 92123

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Seattle, Washington, 98101

  • Study site

    Skokie, Illinois, 60076

  • Study site

    Skokie, Illinois, 60077

  • Study site

    Somerset, New Jersey, 08873

  • Study site

    Soquel, California, 95073

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Springfield, Illinois, 62702

  • Study site

    Staten Island, New York, 10305

  • Study site

    Thomasville, Georgia, 31792

  • Study site

    Towson, Maryland, 21204

  • Study site

    Tucson, Arizona, 85715

  • Study site

    Tyler, Texas, 75701

  • Study site

    Urbana, Illinois, 61801

  • Study site

    Vista, California, 92083

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Woodbridge, Virginia, 22191

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

Canada17 sites

  • Study site

    Barrie, Ontario, L4M 6M2

  • Study site

    Calgary, Alberta, T2N4N2

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Fleurimont, Quebec, J1H 5N4

  • Study site

    Halifax, Nova Scotia, B3H 1V7

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    Lévis, Quebec, G1V3Z1

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    North Vancouver, British Columbia, V7L 2L7

  • Study site

    Pointe-Claire, Quebec, H9R4S3

  • Study site

    Québec, Quebec, G1R2J6

  • Study site

    Richmond, British Columbia, V6X1A2

  • Study site

    Saskatoon, Saskatchewan, S7N4H4

  • Study site

    Toronto, Ontario, M4C-3E7

  • Study site

    Toronto, Ontario, M4N 3N5

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Toronto, Ontario, M5G 2m9

Other trials in Canada

About this study

Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.

Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

Being tested
Temsirolimus (CCI-779) for 34 months, Letrozole for 34 months
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temsirolimus (CCI-779) for 34 monthsDrug

  • Letrozole for 34 monthsDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine overall progression free survival.

Secondary outcomes (1)

  1. To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,236 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083993
Sponsor's protocol ID
3066A1-303
Status last verified
Nov 2011
First submitted
4 Jun 2004
Last updated
8 Nov 2011
Results posted
No

Publications

  • Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, Sun Y, Neskovic-Konstantinovic Z, Guimaraes RC, Fumoleau P, Chan A, Hachemi S, Strahs A, Cincotta M, Berkenblit A, Krygowski M, Kang LL, Moore L, Hayes DF. Randomized phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013 Jan 10;31(2):195-202. doi: 10.1200/JCO.2011.38.3331. Epub 2012 Dec 10.

    PubMed 23233719

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Temsirolimus (CCI-779) for 34 months and Letrozole for 34 months in people with Breast Neoplasms and Neoplasm Metastasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 129 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine overall progression free survival.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.

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