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Phase II Study of Everolimus Beyond Progression | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Phase II Study of Everolimus Beyond Progression

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

NCT02269670•Emory University

View on ClinicalTrials.gov

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. 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.

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.

Eligibility

Age

19 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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
•Absolute neutrophil count (ANC) \> 1,500/µL
•Platelets ≥ 100,000/µL
•Hemoglobin \> 10 g/dL
•Creatinine ≤ 1.5 x upper limit of normal (ULN)
+6 more criteria

Exclusion Criteria

•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
•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
+15 more criteria

Locations (3)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Key Dates

Start Date

November 25, 2014

Primary Completion Date

January 25, 2021

Completion Date

January 25, 2021

Last Updated

April 5, 2022

Enrollment

ACTUAL participants

Conditions

Estrogen Receptor-positive Breast CancerHER2-negative Breast CancerProgesterone Receptor-positive Breast CancerRecurrent Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Interventions

everolimus

DRUG

anastrozole

DRUG

letrozole

DRUG

tamoxifen citrate

DRUG

fulvestrant

DRUG

megestrol acetate

DRUG

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

NCT07483307

Breast CancerHER2-negative Breast Cancer+2 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study of Everolimus Beyond Progression

Inclusion Criteria

Exclusion Criteria

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer