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NCT Number: NCT02248571

Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab

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.

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Key information

Conditions

Breast Cancer Recurrent Breast Diseases Breast Neoplasms HER2/Neu-negative Carcinoma of Breast Hormone Receptor Positive Malignant Neoplasm of Breast Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent must be obtained prior to any study specific procedure.

  • Adult women (≥ 18 years of age)
  • . 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.

  • Pathologically confirmed HER2/neu-negative, ER/PR positive inoperable or metastatic adenocarcinoma of the breast
  • 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)
  • No indication for other chemotherapeutic treatment including Taxanes or Anthracyclines
  • Measurable or non-measurable disease as per RECIST 1.1
  • Adequate bone marrow, liver and renal function (according to current SmPCs of both treatment regimens)
  • ECOG performance status 0-2
  • Fluent German (spoken and written) language

Exclusion criteria

  • Prior palliative cytotoxic chemotherapies
  • Prior exposure to mTOR-Inhibitors (prior treatment with exemestane is allowed)
  • Concomitant antihormonal therapies, other than study medication
  • Symptomatic visceral metastases (as deemed by the investigator)
  • Uncontrolled CNS metastases
  • Unstable skeletal metastases
  • Medically uncontrolled cardiovascular diseases (e.g. uncontrolled hypertension)
  • Medically uncontrolled diabetes mellitus
  • Severe hepatic impairment (Child-Pugh C)
  • 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]
  • Known HIV infection or chronic hepatitis B or C or history of hepatitis B or C
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Any other contraindications to the study drugs used or their excipients according to current SmPCs
  • Concomitant use of immunosuppressive agents or chronic use of systemic corticosteroids
  • Use of any other concomitant medication known to interfere with the study drugs
  • Use of concomitant medication known to interfere with the study results (e.g. hormonal therapy) during the whole study duration
  • Premenopausal patients
  • Pregnant or breast feeding patients
  • Participation in additional parallel interventional drug or device studies within four weeks before start of study.

Treatment and study plan

Bevacizumab

Drug

administered as combined therapy with Capecitabine

Other names: Avastin®

Capecitabine

Drug

administered as combined therapy with Bevacizumab

Everolimus

Drug

administered as combined therapy with Exemestane

Other names: Afinitor®

Exemestane

Drug

administered as combined therapy with Everolimus

Patient questionaires

Other

Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference

Other names: Papient reported outcome, Patients' preference

Primary outcomes

  1. Patients' preference

    Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation

    Patients' preference of the two treatment combinations capecitabine plus bevacizumab or everolimus in combination with exemestane after failure of standard antihormonal therapy in patients with advanced (inoperable or metastatic) HER2/neu-negative hormone receptor positive breast cancer.

    The preference will be ascertained using the patient preference questionnaire.

Secondary outcomes

  1. Reasons for patients' preference

    Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation

    To evaluate reasons for preference as assessed by the patient preference questionnaire

  2. Patient reported treatment satisfaction

    Time frame: After 12 weeks of first and second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation of each treatment phase

    To compare patient reported treatment satisfaction as assessed by the treatment satisfaction questionnaire in first- and second treatment phase

  3. Quality of life

    Time frame: At baseline and after 12 weeks of first and second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation of each treatment phase

    To investigate differences in quality of life by the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC QLQ-C30) and EORTC QLQ-FA13 questionnaire

  4. Progression free survival rate

    Time frame: After 12 weeks of first and second treatment phase

    To assess progression free survival rates after 12 weeks of therapy in first- (PFS rate 1) and second treatment phase (PFS rate 2)

  5. Objective response rates and disease control rates based on tumor assessment (RECIST 1.1)

    Time frame: Participants will be followed for the whole duration of first phase therapy, with an expected average of 12 months, plus 3 months of second phase therapy (15 months in total)

    To assess clinical benefit by determining objective response rates and disease control rates based on tumor assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

  6. Safety and tolerability as measured by number of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities

    Time frame: From date of informed consent to +30 days from last application of study medication

    To evaluate safety and tolerability throughout the study according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.03 criteria, including clinical laboratory (grades 3 or 4 - separately for hematology and biochemistry) and number of treatment-emergent AEs (safety data for pre- and post-treatment periods will be listed separately)

  7. Physicians' treatment preference

    Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation

    To determine physicians' treatment preference as assessed by the physician preference questionnaire

  8. Progression free survival for first and second treatment phase

    Time frame: Participants will be followed until progressive disease in boths treatment phases (expected 21 months in total)

    To explore progression free survival separately for each treatment phase

  9. Overall survival

    Time frame: Participants will be followed until death (expected median of 24 months)

    To explore overall survival for each treatment arm beginning from start of respective treatment phase until end of follow-up phase

Other outcomes

  1. Relationship Quality of life scores / patient preference

    Time frame: At baseline and after 12 weeks of first and second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation of each treatment phase

    To explore relationship between QoL scores and patient preference (Exploratory objective)

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Arbeitsgemeinschaft fur Internistische Onkologie
  • Novartis Pharmaceuticals

Registry information

Official study 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

Acronym: IMPROVE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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