Dose monitoring of commonly used cytostatic drugs for breast cancer
Phase 1
- Conditions
- ewly diagnosed pre- or post-operative breast cancerMedDRA version: 21.1Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000641-44-SE
- Lead Sponsor
- Karolinska intitutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 280
Inclusion Criteria
1. Female patients aged = 18 years.
2. Treated with any, or a combination, of the drugs cyclophosphamide, epirubicin, doxorubicin, docetaxel and paclitaxel.
3. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Exclusion Criteria
1. Patients fulfilling any of the contraindications mentioned for the studied drugs.
2. Patients treated with a combinatorial regime of docetaxel, carboplatin and trastuzumab.
3. A decision of exclusion is taken by the treating oncologist at the respective oncological clinic.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method