Phase 3
Completed N=98
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
Anatomic Stage 0 Breast Cancer AJCC v8 · Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Anatomic Stage IB Breast Cancer AJCC v8
Source: ClinicalTrials.gov NCT04862585 ↗
Enrolled (actual)
98
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing — 0; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing |
0; 1 | — |
| SECONDARY Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) |
2.5; 1; 3.3; 2.3; 1.7; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to receive at least 4 doses of paclitaxel as a single-agent or in combination with trastuzumab, pertuzumab, bevacizumab, pembrolizumab, lapatinib, gemcitabine or other drug combination (excluding cisplatin or carboplatin) for the treatment of any stage, histologically confirmed breast cancer
- Ability to complete questionnaires by themselves or with assistance
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age >= 18
- Able to give informed consent
- Patients must be scheduled to receive prophylactic HSR premedications (IV or oral) consisting of a histamine-1 (H1) antagonist (diphenhydramine) or cetirizine (a histamine-1 (H1) antagonists), dexamethasone (a steroid) and a either famotidine, ranitidine or cimetidine (histamine-2 (H2) antagonists), per institutional guidelines, prior to each of their first 2 doses of paclitaxel
- Patients may enroll, or currently be enrolled in another concurrent clinical trial provided the other trial would not prohibit the discontinuation of paclitaxel premedications
Exclusion Criteria
- Patients who have received at least 1 prior lifetime dose of paclitaxel or paclitaxel albumin-bound
- Patients receiving paclitaxel in combination with carboplatin or cisplatin (due to risk of hypersensitivity with platinum compounds)
- History of grade 3 hypersensitivity reaction to Cremophor EL containing medications (e.g. paclitaxel, cyclosporine, ixabepilone, teniposide)
- Patients receiving therapeutic daily doses of systemic corticosteroids. Intermittent oral steroids for nausea or for acute inflammatory conditions (i.e. methylprednisolone dosepak) and inhaled, intranasal or topical corticosteroids are permitted
- Patients who are pregnant or nursing. Paclitaxel is classified by the Food and Drug Administration (FDA) as "pregnancy category D". Pregnancy testing (urine or blood human chorionic gonadotropin [Hcg]) will be done and documented prior to enrollment if pregnancy is clinically suspected
Data sourced from ClinicalTrials.gov (NCT04862585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.