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Estrogen Receptor-positive Breast CancerPhase 2NCT02269670

Phase II Study of Everolimus Beyond Progression

A Phase 2 study testing everolimus, anastrozole and letrozole in people with Estrogen Receptor-positive Breast Cancer and HER2-negative Breast Cancer, run by Emory University at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
everolimus, anastrozole and letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
3 sitesUnited States
Study dates
25 Nov 2014to 25 Jan 2021
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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Estrogen (ER) and/or progesterone (PR)-positive at primary diagnosis and at metastatic diagnosis where tissue is available (defined as > or = 1% of staining nuclei)
  • Progressive or recurrent breast cancer defined as disease progression or recurrence while on a combination of exemestane with everolimus
  • Human epidermal growth factor receptor 2 (HER2)/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH] negative if IHC 2+) at primary diagnosis
  • Histologically confirmed, measurable or evaluable disease; patients should have at least one measurable lesion; if applicable, Response Evaluation Criteria in Solid Tumors (RECIST) criteria should be used
  • Life expectancy > 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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  • Absolute neutrophil count (ANC) > 1,500/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin > 10 g/dL
  • Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 x ULN
  • International normalized ratio ≤ 1.3 (or ≤ 3 on anticoagulants)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x ULN unless related to primary disease
  • Signed informed consent
  • Adequate birth control
  • 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

Who cannot join

  • Prior treatment with everolimus other than in combination with hormonal therapy for treatment of breast cancer or prior treatment with another mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus) for any indication
  • HER2 positive disease as defined by 3+ IHC or positive FISH (both in primary and metastatic sites)
  • Active infection: temperature > 100 Fahrenheit (F), fever of unknown origin, active symptoms or signs of infection as defined by the investigator
  • Uncontrolled central nervous system metastases
  • Life-threatening, visceral metastases
  • Pregnant or lactating women
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  • Prior chemotherapy within the last 4 weeks
  • Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)
  • Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
  • Hypersensitivity to trial medications (everolimus)
  • Emotional limitations, which the investigator judges could limit the patient's ability to follow up and comply with study procedures
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
  • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
  • Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • A known history of human immunodeficiency virus (HIV) seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of EVEROLIMUS (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 EVEROLIMUS)
  • Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  • Taking any of the following agents:
  • Chronic treatment with systemic steroids or another immunosuppressive agent (use of steroids as part of management of everolimus toxicities will be allowed)
  • Live vaccines
  • 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, bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a typhoid vaccines
  • Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer

This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a different type of hormone therapy may be an effective treatment for breast cancer in patients who progressed on everolimus with exemestane.

Read the detailed description

PRIMARY OBJECTIVE:

Progression free survival in patients with advanced or metastatic breast cancer receiving everolimus plus hormonal therapy beyond first progression.

SECONDARY OBJECTIVES:

  1. Clinical benefit rate (sum of stable disease, partial response, complete response).
  2. Response rate (partial response and complete response).
  3. Overall survival.
  4. Safety, side effects and tolerability profile of everolimus.

OUTLINE:

Patients receive everolimus orally (PO) daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant intramuscularly [IM] or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO 4 times daily [QID]; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.

Being tested
everolimus, anastrozole, letrozole, tamoxifen citrate, fulvestrant
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 42-O-(2-hydroxy)ethyl rapamycin, Afinitor, RAD001

    Given PO

  • anastrozoleDrug

    Also called ANAS, Arimidex, ICI-D1033

    Given PO

  • letrozoleDrug

    Also called CGS 20267, Femara, LTZ

    Given PO

  • tamoxifen citrateDrug

    Also called Nolvadex, TAM, tamoxifen, TMX

    Given PO

  • fulvestrantDrug

    Also called Faslodex, ICI 182,780

    Given IM or PO

  • megestrol acetateDrug

    Also called BDH 1298, Maygace, Megace, Megestil

    Given PO

Study groups in NCT02269670
Study groupRoleWhat they receive
Treatment (everolimus, hormone therapy)ExperimentalPatients receive everolimus PO daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant IM or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO QID; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Drug: everolimus; Drug: anastrozole; Drug: letrozole; Drug: tamoxifen citrate; Drug: fulvestrant; Drug: megestrol acetate

What is being measured

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

  1. Response Rate (Partial Response Plus Complete Response) Using RECIST

    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

    Measured: Up to 2 years

  2. Progression-free Survival (PFS)

    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Clinical Benefit Rate (Response Rate Plus Stable Disease)

    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

    Measured: Up to 2 years

  2. Overall Survival (OS)

    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

    Measured: From the initiation of alternate hormonal treatment in combination with everolimus to time of death from any cause, assessed up to 2 years

  3. Incidence of Adverse Events Assessed Using Common Terminology Criteria for Adverse Events Version 4.0

    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

    Measured: Up to 2 years

Timeline

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

  1. First posted21 Oct 2014 (estimated)
  2. Study start25 Nov 2014
  3. Primary completion25 Jan 2021
  4. Study completion25 Jan 2021

Why it stopped: Slow to accrual

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02269670
Sponsor's protocol ID
IRB00071229
Other IDs
NCI-2014-02092, WINSHIP2563-13
Status last verified
Mar 2022
First submitted
17 Oct 2014
Last updated
5 Apr 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing everolimus, anastrozole and letrozole in people with Estrogen Receptor-positive Breast Cancer and HER2-negative Breast Cancer, run by Emory University 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 16 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: stopped early, as of the sponsor's last update on 5 Apr 2022. 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 5 Apr 2022). 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?

Response Rate (Partial Response Plus Complete Response) Using RECIST (time frame: Up to 2 years). The study lists 2 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 NCT02269670.

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 5 Apr 2022.

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