Breast NeoplasmsPhase 2NCT01088893
Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy
A Phase 2 study testing Everolimus in people with Breast Neoplasms, run by Organisation for Oncology and Translational Research at 1 site in China.
Trial summary
This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy. Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Mar 2013
- 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
- Women aged ≥ 18 years;
- Histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
- Tumor of 3 cm or greater at time of diagnosis
- Measurable primary tumor after neoadjuvant treatment before randomization
- No prior chemotherapy for breast cancer;
- ECOG performance status ≤1 or Karnofsky performace status ≥ 70%
Show all 10Show fewer
- Adequate liver/renal function
- Able to swallow whole tablets.
- Able to give written informed consent
- Able to follow prescription instructions reasonably well
Who cannot join
- Male patient
- Prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
- Distant metastasis, including skin involvement beyond the breast area
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
Louis Chow, MD contact
China1 site, 1 recruiting
- Recruiting
Unimed Medical Institute
Hong Kong
Louis Chow, MD, (852)28610286
About this study
Official title: A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy
This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.
Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.
- Conditions
- Breast Neoplasms
- Being tested
- Everolimus
- Keywords
- everolimus, neoadjuvant, m-TOR inhibitor
- 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
10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
| Study group | Role | What they receive |
|---|---|---|
| observation | No intervention | Not described |
| Everolimus | Experimental | Not described Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure change of biomarkers in pre- and post- surgery samples
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organisation for Oncology and Translational Research
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088893
- Sponsor's protocol ID
- OOTR-N006
- Status last verified
- May 2012
- First submitted
- 11 Aug 2009
- Last updated
- 24 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01088893
- Acronym / sponsor ID
- OOTR-N006
- Conditions
- Breast Neoplasms
- Keywords
- everolimus, neoadjuvant, m-TOR inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Organisation for Oncology and Translational ResearchUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 17 Mar 2010 (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.
This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.
Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | No intervention | – |
| Everolimus | Experimental | Drug: Everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged ≥ 18 years;
- Histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
- Tumor of 3 cm or greater at time of diagnosis
- Measurable primary tumor after neoadjuvant treatment before randomization
- No prior chemotherapy for breast cancer;
Key exclusion criteria (4 listed)
- Male patient
- Prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
- Distant metastasis, including skin involvement beyond the breast area
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
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 |
|---|---|---|
| Everolimus10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery | Drug | Everolimus |
Primary outcome
measure change of biomarkers in pre- and post- surgery samples
Time frame: baseline and 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Louis Chow, MD contact
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 in people with Breast Neoplasms, run by Organisation for Oncology and Translational Research at 1 site in China.
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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 May 2012. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis Chow, MD ((852)28610286), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure change of biomarkers in pre- and post- surgery samples (time frame: baseline and 1 month). 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 24 May 2012.