Breast NeoplasmPhase 2NCT00107016
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
A Phase 2 study testing RAD001, Letrozole 2.5mg and Letrozole 2.5mg in people with Breast Neoplasm, run by Novartis Pharmaceuticals at 46 sites in 10 countries.
Trial summary
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- RAD001, Letrozole 2.5mg and Letrozole 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 46 sitesin 10 countries
- Study dates
- Mar 2005to Apr 2007
- Phase
- Phase 2
- 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
- Histologically-confirmed diagnosis of invasive breast cancer, previously untreated
- Patients must be postmenopausal
- Candidates for mastectomy or breast-conserving surgery
- Primary tumor of above 2 cm diameter, measured by imaging
- Clinical Stage M0
- WHO performance status ≤1
- Adequate bone marrow, liver, and renal function
Who cannot join
- Multicentric invasive tumors
- Bilateral or inflammatory breast cancer
- Receiving concomitant anti-cancer treatments such as chemotherapy
- Patients with an uncontrolled infection
- Patients with other concurrent severe and/or uncontrolled medical disease
- Additional protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
46 sites in 10 countries.
46 sites in 10 countries
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Roswell Park Cancer Institute
Buffalo, New York, 14263
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46254
Breastlink Medical Group Inc.
Long Beach, California, 90806
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
UPMC / Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
UCSF Breast Care Center
San Francisco, California, 94115
Highlands Oncology Group
Springdale, Arkansas, 72764
Germany8 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Erlangen
Novartis Investigative Site
Frankurt Am Main
Novartis Investigative Site
Jena
Novartis Investigative Site
Kiel
Novartis Investigative Site
München
Novartis Investigative Site
Regensburg
Novartis Investigative Site
Tübingen
Spain6 sites
Novartis Investigative Site
Alicante
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Madrid
Novartis Investigative Site
Valencia
Novartis Investigative Site
Zaragoza
France5 sites
Novartis Investigative Site
Besançon
Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Montpellier
Novartis Investigative Site
Paris
Novartis Investigative Site
Saint-Herblain
United Kingdom5 sites
Novartis Investigative Site
Chelmsford
Novartis Investigative Site
Edinburgh
Novartis Investigative Site
Epping
Novartis Investigative Site
London
Novartis Investigative Site
Whittington
Italy4 sites
Novartis Investigative Site
Florence
Novartis Investigative Site
Milan
Novartis Investigative Site
Naples
Novartis Investigative Site
Torino
Russia3 sites
Novartis Investigative Site
Chelyabinsk
Novartis Investigative Site
Kazan'
Novartis Investigative Site
Saint Petersburg
Austria2 sites
Novartis Investigative Site
Salzburg
Novartis Investigative Site
Vienna
Canada2 sites
Novartis Investigative Site
Natasha
Novartis Investigative Site
Winnipeg
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
- Conditions
- Breast Neoplasm
- Being tested
- RAD001, Letrozole 2.5mg, Letrozole 2.5mg
- Keywords
- Breast Cancer, Cancer of the Breast, Neo-adjuvant, Primary breast cancer, postmenopausal, pre-operative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001, Letrozole 2.5mgDrug
Letrozole 2.5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| RAD001 + letrozole 2.5mg | Experimental | Not described Receives: Drug: RAD001, Letrozole 2.5mg |
| Letrozole 2.5mg | Active comparator | Not described Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
Secondary outcomes (1)
To assess the four month treatment as being predictive of clinical tumor response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107016
- Sponsor's protocol ID
- CRAD001C2222
- Status last verified
- Feb 2013
- First submitted
- 4 Apr 2005
- Last updated
- 4 Mar 2013
- Results posted
- No
Publications
Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol. 2009 Jun 1;27(16):2630-7. doi: 10.1200/JCO.2008.18.8391. Epub 2009 Apr 20.
PubMed 19380449
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00107016
- Acronym / sponsor ID
- CRAD001C2222
- Conditions
- Breast Neoplasm
- Keywords
- Breast Cancer, Cancer of the Breast, Neo-adjuvant, Primary breast cancer, postmenopausal, pre-operative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 5 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAD001 + letrozole 2.5mg | Experimental | Drug: RAD001, Letrozole 2.5mg |
| Letrozole 2.5mg | Active comparator | Drug: Letrozole 2.5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-confirmed diagnosis of invasive breast cancer, previously untreated
- Patients must be postmenopausal
- Candidates for mastectomy or breast-conserving surgery
- Primary tumor of above 2 cm diameter, measured by imaging
- Clinical Stage M0
Key exclusion criteria (6 listed)
- Multicentric invasive tumors
- Bilateral or inflammatory breast cancer
- Receiving concomitant anti-cancer treatments such as chemotherapy
- Patients with an uncontrolled infection
- Patients with other concurrent severe and/or uncontrolled medical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001, Letrozole 2.5mg | Drug | RAD001 + letrozole 2.5mg |
| Letrozole 2.5mg | Drug | Letrozole 2.5mg |
Primary outcome
To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
1 secondary outcome
To assess the four month treatment as being predictive of clinical tumor response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Derived from this study: PubMed 19380449Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol. 2009 Jun 1;27(16):2630-7. doi: 10.1200/JCO.2008.18.8391. Epub 2009 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001, Letrozole 2.5mg and Letrozole 2.5mg in people with Breast Neoplasm, run by Novartis Pharmaceuticals at 46 sites in 10 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany, Spain, France, United Kingdom and 5 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women. 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 NCT00107016, 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 4 Mar 2013.