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A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (BOLERO-5)

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ClinicalTrials.gov Identifier: NCT03312738
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This study aims at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- ABC after recurrence or progression on letrozole or anastrozole.

The rationale of this study is based on the following:

  • Proven everolimus activity in breast cancer in combination with exemestane
  • Efficacy and manageable safety profile of everolimus in combination with exemestane in the Asian subpopulation of BOLERO-2

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Everolimus Drug: Exemestane Drug: Everolimus Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: this is a double-blind, randomized, placebo-controlled study, parallel groups,
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blinded study
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Phase II Study of Everolimus in Combination With Exemestane in the Treatment of Chinese Postmenopausal Women With Estrogen Receptor Positive, HER-2 Negative, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Everolimus + Exemestane
Everolimus 10mg/Day + Exemestane 25mg/Day
Drug: Everolimus
Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
Other Name: RAD001
Drug: Exemestane
Exemestane 25 mg orally daily.
Active Comparator: Placebo + Exemestane
Placebo of everolimus in combination with exemestane 25 mg daily
Drug: Exemestane
Exemestane 25 mg orally daily.
Drug: Everolimus Placebo
Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.



Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: date of randomization to the date of the first documented progression or death from any cause which ever occur first, up to approximatly 19 months. ]
    Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. PFS will be analyzed when approximately 110 events are reached.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC). [ Time Frame: date of randomization to the date of the first documented progression or death from any cause which ever occur first, up to approximatly 19 months. ]
    PFS in the two treatment arms as determined by a Blinded Independent Review Committee (BIRC).

  2. Overall survival [ Time Frame: date of randomization to date of death up to approximately 19 months ]
    Overall survival (OS) in the two treatment arms

  3. Overall response rate (ORR) [ Time Frame: date of randomization to the date of the first documented progression or death from any cause which ever occur first, up to approximatly 19 months. ]
    Overall response rate (ORR) defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR). ORR will be analysed when approximatly 110 events are reached.

  4. Clinical benefit rate (CBR) [ Time Frame: date of randomization to the date of the first documented progression or death from any cause which ever occur first, up to approximatly 19 months ]
    CBR, defined as the proportion of patients with best overall response of complete response (CR), partial response (PR) or stable disease (SD) with duration of 24 weeks or longer. CBR will be analyzed when approximately 110 events are reached.

  5. Time to response [ Time Frame: date of randomization to the date of the first documented progression or death from any cause which ever occur first, up to approximatly 19 months. ]
    Time to response, defined as the time between date of randomization until first documented response (CR or PR). it will be analyzed when approximately 110 events are reached.

  6. Duration of Response DOR [ Time Frame: date of first documented CR or PR to date of first documented disease progression or death due to any cause up to apprximately 19 months ]
    DOR, defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause

  7. ECOG [ Time Frame: date of randomization up to approximately 19 months ]
    Time to deterioration of ECOG Performance Status


Other Outcome Measures:
  1. Pharmacokinetics of everolimus (Cmin) [ Time Frame: predose, two hours post dose ]
    Characterize the pharmacokinetics of everolimus (Cmin, C2h) when administered



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.

  • Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
  • Postmenopausal women. Postmenopausal status is defined either by:

    • Prior bilateral oophorectomy
    • Or age ≥60
    • Or age < 60 and amenorrhea for 12 or more months
  • Recurrence or progression on prior NSAI is defined as:

    • Recurrence while on, or within one year (12 months) of end of adjuvant treatment with letrozole or anastrozole OR
    • Progression while on or within one month (30 days) of the end of prior treatment with letrozole or anastrozole
  • Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment
  • Patient must have as per RECIST 1.1

    • measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.

    8. Patient is able to swallow and retain oral medication 9. Patient must meet the hematologic & biochemistery laboratory values at the screening visit:

  • Written informed consent must be obtained prior to any screening procedures

Exclusion Criteria:

  • Patients eligible for this study must not meet any of the following criteria:
  • HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test. Note: Patients with IHC 2+ must have a negative in situ hybridization test.
  • Patients who received more than one chemotherapy line for ABC
  • Patient with symptomatic visceral disease and is candidate to chemotherapy
  • Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis (e.g. pleural effusion, ascites etc.)
  • Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except topical applications, inhaled sprays, eye drops or local injections.
  • Uncontrolled diabetes mellitus as defined by HbA1c >7% despite adequate therapy.

Other protocol-defined inclusion/exclusion criteria may apply"


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312738


Contacts
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
China, Heilongjiang
Novartis Investigative Site Recruiting
Harbin, Heilongjiang, China, 150081
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03312738     History of Changes
Other Study ID Numbers: CRAD001Y2202
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
everolimus
exemestane
advanced Breast Cancer
non-steroidal aromatase inhibitors
breast carcinoma
breast cancer
breast lump
HER2 negative
breast cancer progression

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Everolimus
Sirolimus
Disease Progression
Recurrence
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Exemestane
Estrogens
Aromatase Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists