Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients

NCT03860740 | Completed

• 1 other identifier: GEICAM/2014-09
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Luminal B

Keywords

Physical exercise; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Tumor proliferation (Ki67)

  Tumor proliferation (Ki67) will be assessed immunohistochemically at basal biopsies versus post-surgery tumor samples.

  Post-surgery, an average of 6 months

• Proliferation Score

  A 50-gene quantitative polymerase chain reaction (qPCR) assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.

  Post-surgery, an average of 6 months

Secondary Outcomes (9)

• Change from baseline molecular subtypes

  Post-surgery, an average of 6 months

• Changes in tumor microenvironment: levels of Vascular endothelial growth factor (VEGF)

  Post-surgery, an average of 6 months

• Changes in tumor microenvironment: levels of factor Hypoxia-inducible factor 1 (HIF-1)

  Post-surgery, an average of 6 months

• Change in tumor microenvironment: levels of cleaved caspase 3

  Post-surgery, an average of 6 months

• Oxygen uptake during peak exercise (VO2peak)

  Post-surgery, an average of 6 months

Study Arms (2)

High intensity physical exercise

Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.

Other: Exercise

Control

Supervised Stretching Group: a stretching and body balance classes will be developed to control the possible confounders and to control the exercise level of participants.

Other: Stretching

Interventions

Exercise OTHER

Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum

High intensity physical exercise

Stretching OTHER

Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Faculty of Physical Activity and Sport Sciences (INEF): collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (25)

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Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples Blood samples

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Study Director

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

• Study Director

  Fundación Jimenez Díaz

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: March 4, 2019
• Study Start: June 1, 2016
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)