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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- Time to ipsilateral breast tumor recurrence (IBTR) [ Time Frame: 24 months ]Time to ipsilateral breast tumor recurrence (IBTR)
- Time to locoregional recurrence (LRR) [ Time Frame: 24 months ]Time to locoregional recurrence (LRR)
- Time to contralateral breast cancer (CBC) [ Time Frame: 24 months ]Time to contralateral breast cancer (CBC)
- Time to distant metastases (DM) [ Time Frame: 24 months ]Time to distant metastases (DM)
- Breast cancer specific survival (BCSS) [ Time Frame: 24 months ]Rate of death related to breast cancer
- Overall survival (OS) [ Time Frame: 24 months ]Rate of death related to all causes
- 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.
- 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).
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
|Contact: Icro Meattini, MD,Prof||+39 055 794 firstname.lastname@example.org|
|Contact: Noela Gori, Mrs||+39 055 794 email@example.com|
|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|