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Breast CancerPhase 2NECTARNCT01931163

NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer

A Phase 2 study testing Everolimus in people with Breast Cancer and Triple Negative Breast Cancer, run by Jenny C. Chang, MD at 3 sites 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

RATIONALE: Everolimus plus Cisplatin 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: The purpose of this study is to test how effective combining Cisplatin chemotherapy with Everolimus is in treating subjects with triple… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Triple Negative Breast Cancer
What is being tested?
Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
Jul 2013to Jan 2019
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

  • Female patients ≥18 years of age.
  • Clinical/pathological documentation of residual disease after neo-adjuvant therapy.
  • Patients with synchronous bilateral cancers are eligible only if:
  • Index cancer is triple-negative, defined as ER-, PR-, and HER2-.
  • HER2 negative tumors. HER2 negativity must be confirmed by one of the following:
  • FISH-negative (FISH ratio <2.2), or
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  • IHC 0-1+, or
  • IHC 2-3+ AND FISH-negative (FISH ratio <2.2).
  • Estrogen receptor negative and progesterone receptor negative (<10% staining by IHC for estrogen receptor and progesterone receptor).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate hematologic function, defined by:
  • Absolute neutrophil count 2 >1000/mm3
  • Platelet count ≥100,000/mm3
  • Hemoglobin >9 g/dL
  • Adequate liver function, defined by:
  • AST and ALT ≤2.5 x the upper limit of normal (ULN)
  • Total bilirubin ≤1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).
  • Adequate renal function, defined by:
  • Serum creatinine ≤1.5 x ULN
  • Complete staging work-up ≤24 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan.
  • Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
  • Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patient must be accessible for treatment and follow-up.
  • Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
  • Able to swallow and retain oral medication.
  • Patient must be willing to undergo breast biopsies as required by the study protocol.
  • All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.

Who cannot join

  • Women who are pregnant or breastfeeding.
  • History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
  • Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);
  • Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.
  • Patients who have any severe and/or uncontrolled medical conditions such as:
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  • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
  • Symptomatic congestive heart failure of New York heart Association Class III or IV
  • active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
  • known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
  • active, bleeding diathesis;
  • Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  • Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • Inability to comply with study and/or follow-up procedures.
  • Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines.
  • Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;
  • Known history of HIV seropositivity;
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include combination of any two of the following (a+b or a+c or b+c):
  • Use of oral, injected or implanted hormonal methods of contraception or;
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
  • Total abstinence or;
  • Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
  • Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Methodist Hospital

    Houston, Texas, 77030

  • Houston Methodist Hospital Willowbrook

    Houston, Texas, 77070

  • Houston Methodist Hospital Sugar Land

    Sugar Land, Texas, 77479

Other trials in United States

About this study

Official title: Neoadjuvant Phase II Study Of Everolimus Plus Cisplatin In Triple Negative Breast Cancer Patients With Residual Disease After Standard Chemotherapy

RATIONALE: Everolimus plus Cisplatin 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: The purpose of this study is to test how effective combining Cisplatin chemotherapy with Everolimus is in treating subjects with triple negative breast cancer who have residual disease after chemotherapy.

Read the detailed description

This is a phase II clinical trial of everolimus, an mTOR inhibitor, plus cisplatin chemotherapy in patients with triple negative breast cancer (TNBC) who have residual disease after completion of neoadjuvant chemotherapy. Everolimus and cisplatin will be administered for 12 weeks. Patients will undergo surgery after treatment completion. Patients will have breast biopsy prior to receiving the study treatment.

Being tested
Everolimus
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

Study groups in NCT01931163
Study groupRoleWhat they receive
EverolimusExperimentalCisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Receives: Drug: Everolimus

What is being measured

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

  1. Tumor Response

    Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

    Measured: tumor response at 12 weeks after treatment

Timeline

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

  1. First posted29 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJan 2019
  4. Study completionJan 2019

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931163
Sponsor's protocol ID
Pro00008952
Other IDs
IRB(2)#0513-0062, CRAD001 JUST213
Acronym
NECTAR
Status last verified
Jul 2021
First submitted
26 Aug 2013
Last updated
20 Jul 2021
Data monitoring committee
No

Publications

  • Anand K, Patel T, Niravath P, Rodriguez A, Darcourt J, Belcheva A, Boone T, Ensor J, Chang J. Targeting mTOR and DNA repair pathways in residual triple negative breast cancer post neoadjuvant chemotherapy. Sci Rep. 2021 Jan 8;11(1):82. doi: 10.1038/s41598-020-80081-y.

    PubMed 33420229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Breast Cancer and Triple Negative Breast Cancer, run by Jenny C. Chang, MD at 3 sites 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 28 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: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Jul 2021). 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?

Tumor Response (time frame: tumor response at 12 weeks after treatment). 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 NCT01931163, 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 20 Jul 2021.

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