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Anatomic Stage 0 Breast Cancer AJCC v8Phase 2/3NCT04862585

Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

A Phase 2/3 study testing Cimetidine, Dexamethasone and Diphenhydramine in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cimetidine, Dexamethasone and Diphenhydramine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
7 Oct 2021to 21 Jun 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Cimetidine, Dexamethasone, Diphenhydramine, Famotidine, Paclitaxel
Medical subject headings
Breast Carcinoma In Situ, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CimetidineDrug

    Also called Tagamet

    Given IV and/or PO

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given IV and/or PO

  • DiphenhydramineDrug

    Also called FAR 90X2, PM 255, Probedryl, Rigidyl

    Given IV and/or PO

  • FamotidineDrug

    Also called Pepcid, Pepcid AC

    Given IV and/or PO

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Weekly or every 14 day dosing

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • RanitidineDrug

    Given IV and/or PO

Study groups in NCT04862585
Study groupRoleWhat they receive
Arm I (paclitaxel, pre-medications)Active comparatorPatients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Receives: Drug: Cimetidine; Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Famotidine; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Drug: Ranitidine
Arm II (paclitaxel)ExperimentalPatients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Receives: Drug: Paclitaxel; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    The proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the discontinuation arm but decided to restart pre-medications and patients assigned to the continuation arm but demanded to have premedications discontinued as having experienced HSR.

    Measured: Up to 2 years and 8 months

Secondary outcomes (1)

  1. Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL)

    Will determine whether an abbreviated pre-medication regimen results in an improvement in patient-reported quality of life, as measured by an 11-point numerical analog scale (scores range from 0-10 with higher values representing a worse QoL). Both "undesirable appetite increase" and "reported rash" will be rated on this 11-point scale from 0 to 10 with higher values representing a worse undesirable appetite or a worse rash. The "worst reported undesirable appetite increase" and "worst reported rash" scores representing the highest mean score reported at an individual time point for each arm, will be summarized. In addition the change from baseline will be summarized by mean separately by treatment arm. Data will be captured every day, for one week after each dose of chemotherapy.

    Measured: Up to 2 years and 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start7 Oct 2021
  3. Primary completion21 Jun 2024
  4. Study completion21 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862585
Sponsor's protocol ID
OSU-20429
Other IDs
NCI-2021-01586
Status last verified
Aug 2025
First submitted
23 Apr 2021
Last updated
20 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cimetidine, Dexamethasone and Diphenhydramine in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 2 years and 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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