Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
NCT ID: NCT02248571
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2014-08-31
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To identify patients' preference for either therapy in this trial, patients without disease progression or other reasons for early discontinuation will be asked for their treatment preference and their treatment satisfaction. To correlate patients' preference with other patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and throughout the study, using dedicated questionnaires.
With similarly active treatment options, it is of utmost importance to identify the treatment that has the least negative impact on the patients' quality of life.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Bevacizumab plus Capecitabine (1st treatment phase) followed by Everolimus plus Exemestane (2nd treatment phase)
Dosing (treatment cycle: 21days):
1. Capecitabine: 1000 mg/m2 orally applied twice daily as combined 150 mg and 500 mg tablets on days 1 to 14 of each 21-day cycle, followed by a seven day rest period (i.e. off-treatment) --- Bevacizumab: 15 mg/kg intravenously applied once every three weeks (i.e. 5 mg/kg/wk dose equivalent)
2. Everolimus: 10 mg/day orally applied tablet --- Exemestane: 25 mg/day orally applied tablet
Patient questionaires to assess patient reported outcome and patients' preference will be completed at four specific time points during study treatment (two timepoints in each treatment phase)
Bevacizumab
administered as combined therapy with Capecitabine
Capecitabine
administered as combined therapy with Bevacizumab
Everolimus
administered as combined therapy with Exemestane
Exemestane
administered as combined therapy with Everolimus
Patient questionaires
Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference
Arm B
Everolimus plus Exemestane (1st treatment phase) followed by Bevacizumab plus Capecitabine (2nd treatment phase)
Dosing (treatment cycle: 21days):
1. Everolimus: 10 mg/day orally applied tablet --- Exemestane: 25 mg/day orally applied tablet
2. Capecitabine: 1000 mg/m2 orally applied twice daily as combined 150 mg and 500 mg tablets on days 1 to 14 of each 21-day cycle, followed by a seven day rest period (i.e. off-treatment) --- Bevacizumab: 15 mg/kg intravenously applied once every three weeks (i.e. 5 mg/kg/wk dose equivalent)
Patient questionaires to assess patient reported outcome and patients' preference will be completed at four specific time points during study treatment (two timepoints in each treatment phase)
Bevacizumab
administered as combined therapy with Capecitabine
Capecitabine
administered as combined therapy with Bevacizumab
Everolimus
administered as combined therapy with Exemestane
Exemestane
administered as combined therapy with Everolimus
Patient questionaires
Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bevacizumab
administered as combined therapy with Capecitabine
Capecitabine
administered as combined therapy with Bevacizumab
Everolimus
administered as combined therapy with Exemestane
Exemestane
administered as combined therapy with Everolimus
Patient questionaires
Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Adult women (≥ 18 years of age)
2. . Postmenopausal status
The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:
* Age ≥ 55 years and one year or more of amenorrhea
* Age \< 55 years and one year or more of amenorrhea and postmenopausal levels of follicle stimulating hormone (FSH) and Luteinizing hormone (LH) per local institutional standards
* Prior hysterectomy and has postmenopausal levels of FSH and LH per local institutional standards
* Surgical menopause with bilateral oophorectomy
* For women with therapy-induced amenorrhea, oophorectomy or serial measurements of FSH and / or estradiol are needed to ensure postmenopausal status.
Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.
3. Pathologically confirmed HER2/neu-negative, ER/PR positive inoperable or metastatic adenocarcinoma of the breast
4. Indication for systemic palliative targeted therapy / first line chemotherapy after failure of at least one non-steroidal aromatase inhibitor therapy at any time during the disease course (no restriction regarding the number of previous endocrine lines)
5. No indication for other chemotherapeutic treatment including Taxanes or Anthracyclines
6. Measurable or non-measurable disease as per RECIST 1.1
7. Adequate bone marrow, liver and renal function (according to current SmPCs of both treatment regimens)
8. ECOG performance status 0-2
9. Fluent German (spoken and written) language
Exclusion Criteria
2. Prior exposure to mTOR-Inhibitors (prior treatment with exemestane is allowed)
3. Concomitant antihormonal therapies, other than study medication
4. Symptomatic visceral metastases (as deemed by the investigator)
5. Uncontrolled CNS metastases
6. Unstable skeletal metastases
7. Medically uncontrolled cardiovascular diseases (e.g. uncontrolled hypertension)
8. Medically uncontrolled diabetes mellitus
9. Severe hepatic impairment (Child-Pugh C)
10. Inadequate organ function as specified below:
* Hemoglobin \< 9.0 g/dl
* Absolute neutrophil count (ANC) \<1,5 x109/L
* Platelets \<100 x109/L
* Creatinine clearance \< 30ml/min \[Cockcroft and Gault\]
11. Known HIV infection or chronic hepatitis B or C or history of hepatitis B or C
12. Known dihydropyrimidine dehydrogenase (DPD) deficiency
13. Any other contraindications to the study drugs used or their excipients according to current SmPCs
14. Concomitant use of immunosuppressive agents or chronic use of systemic corticosteroids
15. Use of any other concomitant medication known to interfere with the study drugs
16. Use of concomitant medication known to interfere with the study results (e.g. hormonal therapy) during the whole study duration
17. Premenopausal patients
18. Pregnant or breast feeding patients
19. Participation in additional parallel interventional drug or device studies within four weeks before start of study.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arbeitsgemeinschaft fur Internistische Onkologie
OTHER
Novartis Pharmaceuticals
INDUSTRY
iOMEDICO AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Decker, MD
Role: PRINCIPAL_INVESTIGATOR
practice based oncology office Ravensburg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.
Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25.
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792-9. doi: 10.1200/JCO.2005.05.098.
Robert NJ, Dieras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011 Apr 1;29(10):1252-60. doi: 10.1200/JCO.2010.28.0982. Epub 2011 Mar 7.
Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Negrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014 May 10;32(14):1412-8. doi: 10.1200/JCO.2013.50.8267. Epub 2014 Mar 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
iOM-12293
Identifier Type: -
Identifier Source: org_study_id