Clinical trial NCT03860740: Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients
Official title: Effect of Physical Exercise on Ki-67 Levels in Women With Operable Breast Cancer Hormonal Receptor Positive, HER2 Negative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Luminal B
Keywords: Physical exercise
Breast Cancer
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Faculty of Physical Activity and Sport Sciences (INEF)
First posted: 2019-03-04
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers

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 growth factor receptor 2 (HER2)-negative breast cancers

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 benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Tumor proliferation (Ki67)
timeFrame: Post-surgery, an average of 6 months
measure: Proliferation Score
timeFrame: Post-surgery, an average of 6 months
Secondary outcomes:
measure: Change from baseline molecular subtypes
timeFrame: Post-surgery, an average of 6 months
measure: Changes in tumor microenvironment: levels of Vascular endothelial growth factor (VEGF)
timeFrame: Post-surgery, an average of 6 months
measure: Changes in tumor microenvironment: levels of factor Hypoxia-inducible factor 1 (HIF-1)
timeFrame: Post-surgery, an average of 6 months
measure: Change in tumor microenvironment: levels of cleaved caspase 3
timeFrame: Post-surgery, an average of 6 months
measure: Oxygen uptake during peak exercise (VO2peak)
timeFrame: Post-surgery, an average of 6 months
measure: Change in body composition
timeFrame: Post-surgery, an average of 6 months
measure: Change in fatigue levels
timeFrame: Post-surgery, an average of 6 months
measure: Change in quality of life levels
timeFrame: Post-surgery, an average of 6 months
measure: Change in depression levels
timeFrame: Post-surgery, an average of 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Study Director
role: STUDY_DIRECTOR
affiliation: Fundación Jimenez Díaz
name: Study Director
role: STUDY_DIRECTOR
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