Clinical trial · Observational
Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients
Effect of Physical Exercise on Ki-67 Levels in Women With Operable Breast Cancer Hormonal Receptor Positive, HER2 Negative
NCT03860740CI-TRIAL-00063223EFIKcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Luminal B | Luminal B Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
| Stretching | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High intensity physical exercise
- description
- Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.
- interventionNames
- Other: Exercise
- label
- Control
- description
- 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.
- interventionNames
- Other: Stretching
Primary outcomes (2)
- measure
- Tumor proliferation (Ki67)
- timeFrame
- Post-surgery, an average of 6 months
- description
- Tumor proliferation (Ki67) will be assessed immunohistochemically at basal biopsies versus post-surgery tumor samples.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (25)
- BACKGROUNDChirlaque MD, Salmeron D, Ardanaz E, Galceran J, Martinez R, Marcos-Gragera R, Sanchez MJ, Mateos A, Torrella A, Capocaccia R, Navarro C. Cancer survival in Spain: estimate for nine major cancers. Ann Oncol. 2010 May;21 Suppl 3:iii21-29. doi: 10.1093/annonc/mdq082. PMID 20427356
- BACKGROUNDBertolini F. Adipose tissue and breast cancer progression: a link between metabolism and cancer. Breast. 2013 Aug;22 Suppl 2:S48-9. doi: 10.1016/j.breast.2013.07.009. PMID 24074792
- BACKGROUNDMishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2. PMID 22895961
- BACKGROUNDJones LW, Liang Y, Pituskin EN, Battaglini CL, Scott JM, Hornsby WE, Haykowsky M. Effect of exercise training on peak oxygen consumption in patients with cancer: a meta-analysis. Oncologist. 2011;16(1):112-20. doi: 10.1634/theoncologist.2010-0197. Epub 2011 Jan 6. PMID 21212429
- BACKGROUNDHerrero F, San Juan AF, Fleck SJ, Balmer J, Perez M, Canete S, Earnest CP, Foster C, Lucia A. Combined aerobic and resistance training in breast cancer survivors: A randomized, controlled pilot trial. Int J Sports Med. 2006 Jul;27(7):573-80. doi: 10.1055/s-2005-865848. PMID 16802254
- BACKGROUNDJones LW, Demark-Wahnefried W. Diet, exercise, and complementary therapies after primary treatment for cancer. Lancet Oncol. 2006 Dec;7(12):1017-26. doi: 10.1016/S1470-2045(06)70976-7. PMID 17138223
- BACKGROUNDSchmitz KH, Ahmed RL, Yee D. Effects of a 9-month strength training intervention on insulin, insulin-like growth factor (IGF)-I, IGF-binding protein (IGFBP)-1, and IGFBP-3 in 30-50-year-old women. Cancer Epidemiol Biomarkers Prev. 2002 Dec;11(12):1597-604.