Breast CancerPhase 2NCT00855114
Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery
A Phase 2 study testing everolimus and therapeutic conventional surgery in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- everolimus and therapeutic conventional surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2009
- 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
- Diagnosis of invasive breast cancer
- Resectable disease
- Measurable disease, defined as a primary breast mass > 2.0 cm by breast imaging or clinical exam
- Planning to undergo surgical resection after neoadjuvant therapy
- Menopausal status not specified
- Eastern Clinical Oncology Group (ECOG) performance status 0-1
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- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 9.0 g/dL
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
Who cannot join
- Intracranial disease
- Hormone receptor status not specified
- Obese (> 250 pounds)
- Immunosuppression from any cause (e.g., known HIV infection)
- History of severe asthma and/or allergies
- History of severe claustrophobia
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- Ferromagnetic implants, history of shotgun wound and/or shrapnel, cardiac pacemakers, or other similar situations that would be contrary to strong magnetic force
- Bleeding diathesis
- Unstable systemic disease, including but not limited to, any of the following:
- Uncontrolled diabetes
- Severe infection
- Severe malnutrition
- Uncontrolled hypertension
- Unstable angina
- Ventricular arrhythmias
- Active ischemic heart disease
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Chronic liver disease
- Renal disease
- Active upper gastrointestinal tract ulceration
- Less than 4 weeks since prior investigational drug
- Prior therapy with sirolimus or its analogues
- Concurrent immunosuppressive therapy (e.g., steroids, cytotoxic agents, or concurrent radiotherapy)
- Concurrent anticoagulation (i.e., coumadin)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether the administration of everolimus results in a decrease of total choline, a surrogate marker of response, in at least 30% of women with resectable breast cancer.
Secondary
- Determine whether tumors with activated mTOR signaling, as measured by phosphorylation of 4E-BP1 and activity of cap dependent translational complex, will identify those women responsive to everolimus.
OUTLINE: Patients receive oral everolimus once daily on days 1-7 in the absence of disease progression or unacceptable toxicity. Within 24 hours after completing everolimus, patients undergo surgery.
Tumor tissue samples are collected at baseline and during surgery for the analysis of mTOR targets (i.e., 4E-BP1, p70S6 kinase phosphorylation), Ki67, cleaved caspase 3, and activity of cap dependent translational complex by immunohistochemical assays. Patients also undergo MRI/MRS before and after everolimus therapy for total choline and glucose levels measurement.
After completion of study therapy, patients are followed for 30 days.
- Conditions
- Breast Cancer
- Being tested
- everolimus, therapeutic conventional surgery
- Keywords
- stage II breast cancer, stage III breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called RAD001, Afinitor(R)
5 mg/day x 7 days by mouth
therapeutic conventional surgeryProcedure or surgery
Also called surgery
Definitive excision of breast cancer tissue
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated with Everolimus | Experimental | Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery. Receives: Drug: everolimus; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of total choline in at least 30% of patients
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
Measured: Pre-Treatment Compared to Post-Treatment (Day 7)
Secondary outcomes (1)
Identification of response to everolimus by activated mTOR signaling
Two core biopsies will be obtained at the time of diagnostic biopsy. Waste tumor tissue obtained during surgery will be collected at the time of surgery. It will be stored under liquid nitrogen until they can be examined for activation of mTOR targets, specifically, 4E-BP1, p70S6 kinase phosphorylation, and activity of cap dependent translational complex.
Measured: Pre-Treatment Compared to Post-Surgery (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Withdrawn due to no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Yee, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855114
- Sponsor's protocol ID
- 2005LS029
- Other IDs
- 0505M70026
- Status last verified
- Nov 2017
- First submitted
- 3 Mar 2009
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00855114
- Acronym / sponsor ID
- 2005LS029
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage III breast cancer, stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Mar 2009 (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.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine whether the administration of everolimus results in a decrease of total choline, a surrogate marker of response, in at least 30% of women with resectable breast cancer.
Secondary
- Determine whether tumors with activated mTOR signaling, as measured by phosphorylation of 4E-BP1 and activity of cap dependent translational complex, will identify those women responsive to everolimus.
OUTLINE: Patients receive oral everolimus once daily on days 1-7 in the absence of disease progression or unacceptable toxicity. Within 24 hours after completing everolimus, patients undergo surgery.
Tumor tissue samples are collected at baseline and during surgery for the analysis of mTOR targets (i.e., 4E-BP1, p70S6 kinase phosphorylation), Ki67, cleaved caspase 3, and activity of cap dependent translational complex by immunohistochemical assays. Patients also undergo MRI/MRS before and after everolimus therapy for total choline and glucose levels measurement.
After completion of study therapy, patients are followed for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with Everolimus | Experimental | Drug: everolimus, Procedure: therapeutic conventional surgeryBreast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of invasive breast cancer
- Measurable disease, defined as a primary breast mass > 2.0 cm by breast imaging or clinical exam
- Planning to undergo surgical resection after neoadjuvant therapy
- Menopausal status not specified
- Eastern Clinical Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (25 listed)
- Intracranial disease
- Hormone receptor status not specified
- Obese (> 250 pounds)
- Immunosuppression from any cause (e.g., known HIV infection)
- History of severe asthma and/or allergies
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 |
|---|---|---|
| everolimusAlso: RAD001, Afinitor(R)5 mg/day x 7 days by mouth | Drug | Patients Treated with Everolimus |
| therapeutic conventional surgeryAlso: surgeryDefinitive excision of breast cancer tissue | Procedure or surgery | Patients Treated with Everolimus |
Primary outcome
Decrease of total choline in at least 30% of patients
Time frame: Pre-Treatment Compared to Post-Treatment (Day 7)
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
1 secondary outcome
Identification of response to everolimus by activated mTOR signaling
Time frame: Pre-Treatment Compared to Post-Surgery (Day 7)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
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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.
Douglas Yee, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus and therapeutic conventional surgery in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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 15 inclusion and 25 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: withdrawn, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Decrease of total choline in at least 30% of patients (time frame: Pre-Treatment Compared to Post-Treatment (Day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2017.