Breast Carcinoma Clinical Trial
Official title:
Safely Stopping Pre-Medications in Patients Receiving Paclitaxel: A Randomized Trial
This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.
PRIMARY OBJECTIVE: I. To estimate the difference in rates of infusion hypersensitivity reaction (HSR) requiring parenteral rescue medications following the discontinuation of pre-medications after 2 doses of paclitaxel, compared to continuing premedications, in breast cancer patients who have not experienced an infusion HSR with their first 2 paclitaxel doses. OUTLINE: Patients receive paclitaxel per standard of care as a single agent or in combination with dexamethasone intravenously (IV) and/or orally (PO), diphenhydramine IV and/or PO and either famotidine IV and/or PO, ranitidine IV and/or PO or cimetidine IV and/or PO. Patients who don't experience any infusion hypersensitivity reaction after the first 2 doses of paclitaxel are randomized to 1 of 2 arms. ARM I (STANDARD OF CARE): Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel. ARM II (EXPERIMENTAL): Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
| Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
| Active, not recruiting |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
| Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
| Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
| Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
| Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
| Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
| Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
| Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
| Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
| Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
| Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
| Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
| Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
| Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
| Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |