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Breast CancerPhase 2NCT01127763

RAD001 Plus Carboplatin in Breast Cancer Patients

A Phase 2 study testing RAD001 and Carboplatin in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer. 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?
RAD001 and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2010to Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 with metastatic breast cancer (measurable or evaluable including bone metastases only)
  • Histologically confirmed triple negative breast cancer (estrogen receptor (ER)< 10%, progesterone receptor (PR) < 10 %, Her2neu IHC 0 or 1 or FISH negative)
  • Age >= 18 years
  • World Health Organization performance status <= 2
  • Adequate bone marrow function as shown by: absolute neutrophil count ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hb >9 g/dL
  • Adequate liver function as shown by:
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  • serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • international normalized ratio (INR): Patients not on warfarin INR ≤1.5; Patients on warfarin INR ≤3; Patient on stable dose of low molecular weight heparin for >2 weeks at time of treatment is allowed.
  • alanine aminotransferase and aspartate aminotransferase ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
  • Adequate renal function: serum creatinine ≤ 1.5 x ULN
  • 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, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Signed informed consent
  • Patients may have had 0-3 prior regimens for metastatic disease and prior bevacizumab (avastin) is allowed.
  • A baseline lung CT (or PET/CT)
  • O2 sat >= 90% in room air (if <90%, spirometry and diffusion capacity of lung for carbon monoxide (DLCO) above 50% of the normal predicted value of pulmonary function tests)
  • Negative serum pregnancy test within 7 days prior to starting treatment

Who cannot join

  • Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics)
  • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
  • Prior treatment with any investigational drug within the preceding 2 weeks
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first treatment with RAD001. Topical or inhaled corticosteroids are allowed.
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
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  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Symptomatic congestive heart failure of New York heart Association Class III or IV
  • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
  • 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
  • liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA polymerase chain reaction testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
  • Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  • Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Ongoing alcohol or drug addiction

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU Clinical Cancer Center

    New York, New York, 10016

Other trials in United States

About this study

Official title: Phase II Trial of RAD001 Plus Carboplatin in Patients With Triple-Negative Metastatic Breast Cancer

This study investigates the effectiveness of combination of carboplatin and investigational agent RAD001 in triple-negative breast cancer.

Read the detailed description

The primary objective of this study was to determine clinical benefit rate (CBR) i.e.complete remission (CR) + partial remission (PR) + stable disease (SD) lasting ≥ 6 months, and the toxicity of RAD001 /carboplatin in women with metastatic triple-negative breast cancer. Treatment consisted of intravenous carboplatin at area under the plasma concentration-time curve (AUC) 6, later decreased to AUC 5, and subsequently to AUC 4 every 3 weeks with daily 5mg RAD001.

Conditions
Breast Cancer
Being tested
RAD001, Carboplatin
Keywords
metastatic, breast, cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

  • RAD001Drug

    Also called Afinitor, Everolimus

  • CarboplatinDrug

    Also called Paraplatin

Study groups in NCT01127763
Study groupRoleWhat they receive
RAD001+carboplatinExperimentalCarboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
Receives: Drug: RAD001; Drug: Carboplatin

What is being measured

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

  1. Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)

    Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: up to 1 year

  2. Toxicity Profile-Hematological

    Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.

    Measured: treatment period (up to 1 year) plus 30 days off treatment

  3. Toxicity Profile-Non Hematological

    Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.

    Measured: treatment period (up to 1 year) plus 30 days off treatment

Secondary outcomes (1)

  1. Median Progression-free Survival Time

    Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: up to 1 year

Timeline

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

  1. First posted21 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2012
  4. Study completionMar 2013

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127763
Sponsor's protocol ID
NYU 09-0060
Status last verified
Mar 2014
First submitted
19 May 2010
Last updated
9 Apr 2014
Data monitoring committee
Yes

Publications

  • Singh J, Novik Y, Stein S, Volm M, Meyers M, Smith J, Omene C, Speyer J, Schneider R, Jhaveri K, Formenti S, Kyriakou V, Joseph B, Goldberg JD, Li X, Adams S, Tiersten A. Phase 2 trial of everolimus and carboplatin combination in patients with triple negative metastatic breast cancer. Breast Cancer Res. 2014 Mar 31;16(2):R32. doi: 10.1186/bcr3634.

    PubMed 24684785

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RAD001 and Carboplatin in people with Breast Cancer, run by NYU Langone Health 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 16 inclusion and 23 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 9 Apr 2014. 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?

Yes. Results are posted in the registry (first posted 9 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months) (time frame: up to 1 year). The study lists 3 primary outcomes in all. 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 NCT01127763, 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 9 Apr 2014.

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RAD001 Plus Carboplatin in Breast Cancer Patients | AzTrials