Status:
NOT_YET_RECRUITING
Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
Lead Sponsor:
University Hospital of Cologne
Collaborating Sponsors:
St. Elisabeth Krankenhaus Köln-Hohenlind
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative b...
Detailed Description
Recent clinical trials showed promising results in patients with triple negative breast cancer (TNBC) who received four cycles of pembrolizumab (at a dose of 200 mg) every three weeks + standard chemo...
Eligibility Criteria
Inclusion
- Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging
- Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2
- Deemed eligible for intended treatment with Paclitaxel 80mg/m2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg/ m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician
- Treatment in curative intent with life expectancy ≥ 3 months
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.
- Sufficient German language skills;
Exclusion
- History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Any history of previous systemic treatment for TNBC;
- Any diseases that do not allow sports activity, such as:
- Clinically-manifest heart failure (NYHA III-IV);
- Respiratory partial or global insufficiency;
- Permanent thrombocytopenia \<10,000/µl, e.g., refractory autoimmune thrombocytopenia;
- Congenital or acquired thrombocytopathies or coagulation disorders.
- Symptomatic CHD (clearance certificate required, stress ECG and cardiac ultrasound recommended if necessary);
- Participation in another exercise study;
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06497322
Start Date
September 1 2024
End Date
December 31 2027
Last Update
July 11 2024
Active Locations (1)
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1
University Hospital of Cologne and St. Elizabeth Hospital
Cologne, North Rhine-Westphalia, Germany, 50937