Status:
COMPLETED
Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Faculty of Physical Activity and Sport Sciences (INEF)
Conditions:
Breast Cancer
Luminal B
Eligibility:
FEMALE
18+ years
Brief Summary
Observational study to evaluate the effect of physical exercise prior to surgery and adjuvant systemic treatment in women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal g...
Detailed Description
Effect of exercise on tumor aggressiveness and the impact on patients' quality of life. Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral be...
Eligibility Criteria
Inclusion
- Histologically confirmed, previously untreated clinical stage I-IIIA without previous treatment.
- ER positive breast cancer according to local results. (RH+ is defined as ≥ 1% assessed by Immunohistochemistry (IHC) to Estrogen Receptor (ER) and/or Progesterone Receptor (P)E).
- HER2 negative in the primary tumour according to local results. (HER2 confirmation should be done following the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines)
- Scheduled to undergo surgical resection.
- Ki67 levels must be over 13%, according to local results.
- At least 14 days from enrolment to planned surgical resection.
- Karnofsky performance status of at least 70% at study entry or 0-1 level in Eastern Cooperative Oncology Group (ECOG) Scale.
- Signed consent prior to initiation of study-related procedures.
Exclusion
- Schedule to receive any form of induction/neoadjuvant therapy
- Significant cardiac disease (ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within precious 6 months)
- Any pulmonary dysfunction which may affect to the exercise program perform.
- Any mental disease or condition that compromise the physical, psychological and emotional patients' wellness or affect to the process.
- Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03860740
Start Date
June 1 2016
End Date
June 8 2021
Last Update
January 13 2023
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007