Breast CancerPhase 2NCT01163929
A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer
A Phase 2 study testing paclitaxel in people with Breast Cancer, run by University of Kansas.
Trial summary
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Mar 2012
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 to 65 years of age
- Histologically proven stage I, II or III adenocarcinoma of breast
- Candidate for adjuvant chemotherapy and Trastuzumab (Tumor size > 1 cm, T2, T3, T4 and/or clinical N1 or N2)
- HER-2 positive breast cancer (IHC 3+ or FISH ratio of > 2.0)
- ECOG Performance status 0-2
- No prior chemotherapy or HER-2 targeted therapy for breast cancer
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- Not pregnant or breast feeding or adult of reproductive potential using effective birth control methods. If barrier contraceptives are used, these must be continued throughout trial by both sexes. Hormonal contraceptives not acceptable as a sole method of contraception. Women of childbearing potential must have negative urine or serum pregnancy test within 7 days before administration of RAD001
- Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 11 g/dL
- Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min
- Adequate hepatic function: transaminase < 2 x upper limit of normal and total bilirubin < 1.5 mg/dL.
- INR ≤2.0 and PTT 1.5 X the upper limit of institution normal range. Oral anticoagulants, eg,warfarin are CYP2C9 substrates and as such, no interaction with RAD001 is expected. Anticoagulation with Coumadin allowed if target INR is ≤2.0 and stable for > 2 weeks. Anticoagulation with LMWH is allowed.
- Must sign informed consent
- Pretreatment lab values for CBC and CMP performed within 14 days of registration and other baseline studies within 30 days.
- Will have baseline mammogram, bone scan, CT chest and abdomen within 60 days of registration.
- Adequate cardiac function (Cardiac ejection fraction ≥ 50% as measured by echocardiogram or MUGA scan).
- Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, patient can only be included after initiation of appropriate lipid lowering medication.
Who cannot join
- Prior HER-2 targeted therapy for breast cancer
- Metastatic disease
- Uncontrolled intercurrent illness including but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
- GI tract disease resulting in inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease eg, Crohn's, ulcerative colitis).
- Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones)
- Renal function as measured by creatinine clearance <30ml/min (ratio to norm <0.1)
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- Pregnant
- Inflammatory breast cancer
- Active cardiac disease, defined as:
- History of uncontrolled or symptomatic angina
- History of arrhythmias requiring medications, or clinically significant, with exception of asymptomatic atrial fibrillation requiring anticoagulation
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Any other cardiac condition, which in opinion of treating physician, would make this protocol unreasonably hazardous for the patient
- History of another primary cancer, with the exception of:
- curatively resected nonmelanomatous skin cancer
- curatively treated cervical carcinoma in-situ
- other primary solid tumor curatively resected,treated with no known active disease present and no treatment administered for the last 3 years.
- Life expectancy of < 2 months
- Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period
- Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
- Active (acute or chronic) or uncontrolled severe infections
- Known history of HIV seropositivity
- Active, bleeding diathesis
- Patients who have received prior treatment with an mTOR inhibitor (Sirolimus, Temsirolimus, Everolimus).
- Known hypersensitivity to RAD001 (Everolimus) or other rapamycins (Sirolimus, Temsirolimus) or to its excipients
- Active Hepatitis B or C infection
- > 65 years of age
About this study
Official title: A Phase II Neoadjuvant Study of RAD001 (Everolimus) in Combination With Paclitaxel and Trastuzumab For Operable HER2 Positive Breast Cancer
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.
Read the detailed description
This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed, HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant treatment.
The trial has an initial 2 week "biomarker lead in" phase. During this two week phase patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant trial treatment is non randomized open label.
For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly assigned to either receive or not receive Everolimus. This assignment will be accomplished by a previously prepared schedule (maintained by the investigational pharmacy), such that investigators are unaware of assignment until after the subject has been enrolled on the study and received assignment of Everolimus or not.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel
- Keywords
- breast cancer, HER2 positive, Phase II, RAD001, paclitaxel, trastuzumab, everolimus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Taxol, Herception, RAD001
Paclitaxel:
80mg/m2 IV TRO 3 hours every 28 days for 4 cycles
Trastuzumab:
4mg/kg IV load dose (TRO 90) minutes followed by 2 mg/kg TRO 60 minutes every week for 18 weeks
Everolimus: 10mg PO daily 16-18 weeks
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel, trastuzumab and everolimus | Experimental | Not described Receives: Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess complete response rate
To assess the pathological complete response rate (pCR) with of 4 cycles of neoadjuvant Herceptin plus Paclitaxel and Everolimus in patients with operable HER-2 positive breast cancer.
Measured: 5 months
Secondary outcomes (1)
assess objective/radiological response rate and tolerability
The secondary outcome is to assess the objective/radiological response rate and to assess tolerability of the proposed treatment regimen
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Study closed by Protocol Review Monitoring Committee because of lack of 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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Priyanka Sharma, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163929
- Sponsor's protocol ID
- 12186
- Status last verified
- Oct 2012
- First submitted
- 14 Jul 2010
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Neoadjuvant Study of RAD001 (Everolimus) in Combination With Paclitaxel and Trastuzumab For Operable HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01163929
- Acronym / sponsor ID
- 12186
- Conditions
- Breast Cancer
- Keywords
- breast cancer, HER2 positive, Phase II, RAD001, paclitaxel, trastuzumab, everolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed by Protocol Review Monitoring Committee because of lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Jul 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.
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.
Detailed description
This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed, HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant treatment.
The trial has an initial 2 week "biomarker lead in" phase. During this two week phase patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant trial treatment is non randomized open label.
For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly assigned to either receive or not receive Everolimus. This assignment will be accomplished by a previously prepared schedule (maintained by the investigational pharmacy), such that investigators are unaware of assignment until after the subject has been enrolled on the study and received assignment of Everolimus or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel, trastuzumab and everolimus | Experimental | Drug: paclitaxel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female ≥ 18 to 65 years of age
- Histologically proven stage I, II or III adenocarcinoma of breast
- Candidate for adjuvant chemotherapy and Trastuzumab (Tumor size > 1 cm, T2, T3, T4 and/or clinical N1 or N2)
- HER-2 positive breast cancer (IHC 3+ or FISH ratio of > 2.0)
- ECOG Performance status 0-2
Key exclusion criteria (30 listed)
- Prior HER-2 targeted therapy for breast cancer
- Metastatic disease
- Uncontrolled intercurrent illness including but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
- GI tract disease resulting in inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease eg, Crohn's, ulcerative colitis).
- Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones)
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 |
|---|---|---|
| paclitaxelAlso: Taxol, Herception, RAD001Paclitaxel: 80mg/m2 IV TRO 3 hours every 28 days for 4 cycles Trastuzumab: 4mg/kg IV load dose (TRO 90) minutes followed by 2 mg/kg TRO 60 minutes every week for 18 weeks Everolimus: 10mg PO daily 16-18 weeks | Drug | paclitaxel, trastuzumab and everolimus |
Primary outcome
assess complete response rate
Time frame: 5 months
To assess the pathological complete response rate (pCR) with of 4 cycles of neoadjuvant Herceptin plus Paclitaxel and Everolimus in patients with operable HER-2 positive breast cancer.
1 secondary outcome
assess objective/radiological response rate and tolerability
Time frame: 5 months
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 24 Oct 2012.
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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.
Priyanka Sharma, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel in people with Breast Cancer, run by University of Kansas.
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 16 inclusion and 30 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 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
assess complete response rate (time frame: 5 months). 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 Oct 2012.