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ExclUsive endocRine Therapy Or Partial Breast Irradiation for Women Aged ≥70 Years With Luminal-A Early Stage Breast Cancer (EUROPA) (EUROPA)

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ClinicalTrials.gov Identifier: NCT04134598
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Institut Curie
University of Florence
Information provided by (Responsible Party):
Icro Meattini, Azienda Ospedaliero-Universitaria Careggi

Brief Summary:

Rationale and relevance for patients and the scientific community. In low risk early stage patients ≥70 years, exclusive Partial Breast Irradiation (PBI) as radiation therapy (RT) approach might be superior in terms of Health-Related Quality of Life (HRQoL), when compared to exclusive endocrine therapy (ET) following breast-conserving surgery (BCS). Assuming an equal rate of disease control, unnecessary long-term toxicity of ET may be avoided.

Current standard therapy. BCS plus ± RT ± ET (depending on the molecular characterization of tumors in terms of hormonal expression status and national guidelines).


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Partial Breast Irradiation (PBI) Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ExclUsive endocRine Therapy Or Partial Breast Irradiation for Women Aged ≥70 Years With Luminal-A Early Stage Breast Cancer (EUROPA): A Randomized Phase II-III Randomized Controlled Trial Comparing Health Related Quality of Life by Patient Reported Outcome Measures
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Partial Breast Irradiation (PBI)
Partial Breast Irradiation (PBI)
Radiation: Partial Breast Irradiation (PBI)
Irradiation of volume's portion of the residual breast (index quadrant).
Other Name: Partial breast radiotherapy

Active Comparator: Endocrine Therapy (ET)
Endocrine Therapy (ET)
Drug: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
Adjuvant endocrine therapy as per local policy (letrozole/anastrozole/exemestane/tamoxifene for 5-year or switch schedules aromatase inhibitors/tamoxifen for 5-year).
Other Name: Hormonal therapy




Primary Outcome Measures :
  1. Patient reported outcome measures (PROM) HRQoL as assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 [ Time Frame: Change from baseline at 24 months ]
    EORTC Quality of Life Questionnaire (QLQ) C30.The QLQ-C30 is a cancer HRQoL questionnaire using PROMs for individual patient management. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.


Secondary Outcome Measures :
  1. Patient reported outcome measures (PROM) HRQoL as assessed by EORTC Quality of Life Questionnaire (QLQ) BR23 Breast module [ Time Frame: Change from baseline at 24 months ]
    EORTC QLQ BR23 module. The EORTC QLQ BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. All scores are linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. A high QoL is represented by a high score for global health status or QoL. More severe symptoms or problems are represented by high symptom scores or items.

  2. Patient reported outcome measures (PROM) HRQoL as assessed by EORTC Quality of Life Questionnaire (QLQ) ELD14 Elderly module [ Time Frame: Change from baseline at 24 months ]

    EORTC QLQ ELD14 questionnaire. The QLQ ELD14 is a validated HRQoL questionnaire for cancer patients aged ⩾70 years. All scores are linearly transformed to a 0 to 100 scale.

    Five scales: mobility, family support, worries about the future, maintaining autonomy and purpose, and burden of illness. High scores indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.


  3. Time to ipsilateral breast tumor recurrence (IBTR) [ Time Frame: 24 months ]
    Time to ipsilateral breast tumor recurrence (IBTR)

  4. Time to locoregional recurrence (LRR) [ Time Frame: 24 months ]
    Time to locoregional recurrence (LRR)

  5. Time to contralateral breast cancer (CBC) [ Time Frame: 24 months ]
    Time to contralateral breast cancer (CBC)

  6. Time to distant metastases (DM) [ Time Frame: 24 months ]
    Time to distant metastases (DM)

  7. Breast cancer specific survival (BCSS) [ Time Frame: 24 months ]
    Rate of death related to breast cancer

  8. Overall survival (OS) [ Time Frame: 24 months ]
    Rate of death related to all causes

  9. Adverse events (AE) [ Time Frame: 24 months ]
    Number of participants with reported AE. The Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for AE reporting. A grading (severity) scale is provided for each AE term. Grade refers to the severity of the AE. The CTCAE displays Grades 1 (mild) through 5 (death related to AE) with unique clinical descriptions of severity for each AE.

  10. Cosmesis evaluation [ Time Frame: 24 months ]
    Rate of cosmesis assessment grade. The Harvard Breast Cosmesis Scale is a 4-point breast cosmesis grading scale (1. Excellent - 2. Good - 3. Fair - 4. Poor).



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged ≥70 years;
  • histologically proven invasive adenocarcinoma of the breast;
  • pathological T1 (pT1) stage (clinical T1-2 [cT1-2] stage is allowed);
  • clinical and pathological N0 (cN0 and pN0) stage (isolated tumor cells [i+] allowed);
  • any tumor grade (if pT ≤10 mm), G1-2 tumor grade (if pT between 11 and 19 mm);
  • Luminal-A by immunohistochemistry (IHC)-based on local assessment (consistent with 14th St. Gallen consensus definition):

    • ER+ (defined as ≥50% by IHC staining),
    • PgR+ (in any case PgR should be at least >20% by IHC staining),
    • Human epidermal growth factor receptor 2 (HER2)- (0 or 1+ following IHC staining and proven negative by in-situ hybridization [ISH] in case of 2+), and
    • Ki67 ≤20% by IHC staining;
  • surgically treated with BCS with or without sentinel node biopsy (SNB);
  • no clinical evidence of distant metastases. Imaging work up is not mandatory to enter the trial. If there are signs/symptoms suggesting the presence of local relapse or distant metastasis, an appropriate work up should be performed according to the treating physician standard practice. A patient with confirmed local relapse or distant metastasis will no longer be eligible for the trial;
  • postoperative final surgical margins ≥2 mm;
  • baseline HRQoL questionnaires completion;
  • adjuvant bisphosphonates and denosumab are allowed;
  • before patient registration/randomization, written informed consent must be given.

Exclusion Criteria:

  • Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy);
  • current treatment with any hormonal agents such as tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs), either for osteoporosis or BC prevention (patients are eligible if these medications are discontinued prior to randomization);
  • prior breast or thoracic RT;
  • known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosis or scleroderma;
  • prior diagnosis, detection, or treatment of any other invasive cancer (except basal or squamous cell carcinoma of the skin that has been definitely treated);
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before registration;
  • patients must not be considered a poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder.

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): NCT04134598


Contacts
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Contact: Icro Meattini, MD,Prof +39 055 794 7264 icro.meattini@unifi.it
Contact: Noela Gori, Mrs +39 055 794 7264 datamanager.ng.rt@sbsc.unifi.it

Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Institut Curie
University of Florence
Investigators
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Study Chair: Lorenzo Livi, MD,Prof University of Florence, Florence, Italy
Study Chair: Philip M Poortmans, MD,PhD,Prof Institut Curie, Paris, France
Principal Investigator: Icro Meattini, MD,Prof University of Florence, Florence, Italy

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Responsible Party: Icro Meattini, M.D., Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT04134598     History of Changes
Other Study ID Numbers: EUROPA
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icro Meattini, Azienda Ospedaliero-Universitaria Careggi:
Partial Breast Irradiation
Radiation Therapy
Endocrine Therapy
Breast Conserving Surgery
Elderly
Health Related Quality of Life
Patients Reported Outcome Measures
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Anastrozole
Exemestane
Phenobarbital
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
GABA Modulators