Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
Information source: iOMEDICO AG
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer Recurrent; HER2/Neu-negative Carcinoma of Breast; Hormone Receptor Positive Malignant Neoplasm of Breast
Intervention: Bevacizumab (Drug); Capecitabine (Drug); Everolimus (Drug); Exemestane (Drug); Patient questionaires (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: iOMEDICO AG Official(s) and/or principal investigator(s): Thomas Decker, MD, Principal Investigator, Affiliation: practice based oncology office Ravensburg
Overall contact: Stefan Feldner, PhD, Phone: +49 761 15 242, Email: stefan.feldner@iomedico.com
Summary
This is a clinical trial with a crossover design to determine patients' preference for
capecitabine in combination with bevacizumab or everolimus in combination with exemestane
for advanced breast cancer patients and to evaluate, if any combination is associated with a
better quality of life.
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.
Clinical Details
Official title: An Open Label, randomIzed Controlled Prospective Multicenter Two Arm Phase IV Trial to Determine Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab for Advanced (Inoperable or Metastatic) HER2-negative Hormone Receptor Positive Breast Cancer
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Patients' preference
Secondary outcome: Reasons for patients' preferencePatient reported treatment satisfaction Quality of life Progression free survival rate Objective response rates and disease control rates based on tumor assessment (RECIST 1.1) Safety and tolerability as measured by number of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities Physicians' treatment preference Progression free survival for first and second treatment phase Overall survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Written informed consent must be obtained prior to any study specific procedure.
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:
1. Prior palliative cytotoxic chemotherapies
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.
Locations and Contacts
Stefan Feldner, PhD, Phone: +49 761 15 242, Email: stefan.feldner@iomedico.com
iOMEDICO AG, Freiburg, Baden-Wuerttemberg 79108, Germany; Recruiting Stefan Feldner, PhD, Phone: +49 761 15 242, Email: stefan.feldner@iomedico.com Thomas Decker, MD, Principal Investigator
Additional Information
Related publications: 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. Erratum in: Adv Ther. 2014 Sep;31(9):1008-9. 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. Robert NJ, Diéras 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, Négrier 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.
Starting date: August 2014
Last updated: December 23, 2014
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