Clinical trial · Observational
Impact of Body Weight on Pharmacokinetic Analysis of Doxorubicin + Cyclophosphamide in Breast Cancer
Impact of Body Weight on the Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study is classified as ancillary / correlative
Summary
Brief summary (as posted)
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted. The participants must be treated with Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer, Various BMIs
- description
- 18 female breast cancer patients who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese(BMI 25-34.9 kg/m2), or class II-III obese (BMI \> 35 kg/m2).
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females, * age 18 years of age or older, of all racial and ethnic origins that are scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care for breast cancer. * English and/or Spanish speaking participants are eligible to participate. Exclusion Criteria: * Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy and post-partum state would be a confounding variable. * Participants unwilling to comply with study procedures. * CrCl \< 10 ml/min * Participants requiring peritoneal or hemodialysis * Serum bilirubin \> 1.19 mg/dL * Receipt of the following drugs that: * Alter doxorubicin concentrations: carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib, valspodar, verapamil * Alter cyclophosphamide concentrations: cyclosporine, nevirapine, ondansetron * All other drugs will be reviewed during screening of the patient
References
Publications (0)
Data not yet available