Clinical trial · Interventional
BREAST CANCER AND EXERCISE
BREAST CANCER AND EXERCISE BREX: A Multicenter Phase III Open Randomised Trial of the Efficacy of Exercise in the Prevention of Long-term Adverse Effects of Adjuvant Treatments and Breast Cancer Recurrences in Women With Primary Breast Cancer.
NCT00639210CI-TRIAL-00037288BREXcompletedPhase 3ClinicalTrials.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)
A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant treatments and breast cancer recurrences in women with primary breast cancer. The aim of the study is to investigate whether regular exercise training could reduce the long-term side effects of adjuvant treatments of primary breast cancer and improve quality of life and well being.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Help the Patients to Return to Working Life | — | UNRESOLVED | — |
| Improve Quality of Life | — | UNRESOLVED | — |
| Improve Weight Control, and Muscular and Cardiovascular Fitness | — | UNRESOLVED | — |
| Prevent Osteoporosis and Osteoporotic Fractures | — | UNRESOLVED | — |
| Reduce All-cause Mortality in Patients With Primary Breast Cancer | — | UNRESOLVED | — |
| Reduce the Risk of Breast Cancer Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| supervised training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A
- description
- Supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects. The training is guided by an experienced physical therapist.
- interventionNames
- Other: supervised training
- type
- NO_INTERVENTION
- label
- B
Primary outcomes (1)
- measure
- The aim of the study is to investigate whether regular exercise after adjuvant treatments of breast cancer could prevent osteoporosis and improve quality of life.
- timeFrame
- 1-10 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: Histologically proven invasive breast cancer T1-4N0-3M0, pre- or postmenopausal breast cancer patient treated with adjuvant chemotherapy or radiotherapy within 4 months or patient who has started adjuvant endocrine therapy (antiestrogens, aromatase inhibitors, LHRH agonists, or combinations) no later than 4 months earlier,age from 35 to 68 years,signed informed consent prior to beginning protocol specific procedures Exclusion Criteria: * Prior malignancy except basal cell carcinoma or in situ cervix carcinoma * Male gender * Haematogenous metastases (M1) * No systemic adjuvant therapy * Postmenopausal women treated with antiestrogens, tamoxifen or toremifene, adjuvant treatment only (+/- radiotherapy) * Pregnancy or recent lactation (\< 1 year) * Severe cardiac disease (New York Heart Association class III or greater), myocardial infarction within 12 months, uncontrolled hypertension * Verified osteoporosis (proximal femur or lumbar spine t-score \< -2.5 or fracture without trauma) * Concomitant medications affecting calcium and bone metabolism such as bisphosphonates, calcitonin, PTH, SERMs, oral corticosteroids (over 6 months), anticonvulsants (fenytoin, carbamazepine) and prolonged heparin therapy * Other diseases affecting calcium and bone metabolism such as hyperthyroidism, newly diagnosed hypothyroidism, primary hyperparathyroidism, renal failure, chronic hepatic diseases, organ transplant, Cushing's syndrome, rheumatoid arthritis, chronic bowel diseases such as celiac disease, Chron disease or history of total ventricular resection * Other serious illness or medical condition, which could be contraindication for exercise * Patients not capable of training (severe knee arthrosis, severe ligamental or cartilage injuries at lower extremities) * Residence more than one hour from the exercise centre * Competitive athlete
References
Publications (3)
- DERIVEDBlomqvist C, Vehmanen L, Kellokumpu-Lehtinen PL, Huovinen R, Ruohola J, Penttinen H, Sievanen H, Nikander R, Utriainen M, Saarto T. Long-term effects of aromatase inhibitor withdrawal on bone mineral density in early breast cancer patients: 10-year follow-up results of the BREX study. Breast Cancer Res Treat. 2024 Jul;206(1):57-65. doi: 10.1007/s10549-024-07252-7. Epub 2024 Apr 1. PMID 38561578
- DERIVEDPoikonen-Saksela P, Kolokotroni E, Vehmanen L, Mattson J, Stamatakos G, Huovinen R, Kellokumpu-Lehtinen PL, Blomqvist C, Saarto T. A graphical LASSO analysis of global quality of life, sub scales of the EORTC QLQ-C30 instrument and depression in early breast cancer. Sci Rep. 2022 Feb 8;12(1):2112. doi: 10.1038/s41598-022-06138-2. PMID 35136160
- DERIVEDPenttinen HM, Saarto T, Kellokumpu-Lehtinen P, Blomqvist C, Huovinen R, Kautiainen H, Jarvenpaa S, Nikander R, Idman I, Luoto R, Sievanen H, Utriainen M, Vehmanen L, Jaaskelainen AS, Elme A, Ruohola J, Luoma M, Hakamies-Blomqvist L. Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments. Psychooncology. 2011 Nov;20(11):1211-20. doi: 10.1002/pon.1837. Epub 2010 Sep 27. PMID 20878646