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Anti-metabolites

Shorter Chemo-Immunotherapy Without Anthracyclines for Breast Cancer

Q: Could you describe the potential risks associated with Arm II (shorter chemo-immunotherapy)?

<p>Arm II's (shorter chemo-<a href="https://www.withpower.com/clinical-trials/immunotherapy">immunotherapy</a>) safety is valued at 3 on a 1 to 3 scale, as it has undergone numerous evaluations and data collection procedures.</p>

Phase 3

Recruiting

Led By Priyanka Sharma

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis

Participants must be >= 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial compares shorter chemo-immunotherapy without anthracyclines to usual chemo-immunotherapy to treat early-stage triple negative breast cancer. Drugs used to stop cancer cells from growing/dividing & kill them, plus an immunotherapy drug.

Who is the study for?

This trial is for adults with early-stage triple negative breast cancer who haven't had systemic or radiation therapy, or breast surgery for their current cancer. They must have good heart function and no severe allergies to the study drugs. Participants can't be pregnant/nursing and must agree to use contraception. No live vaccines 30 days before joining, no uncontrolled diseases like diabetes or hypertension, and they shouldn't have a history of certain infections or other cancers that could affect the trial.Check my eligibility

What is being tested?

The trial tests if shorter chemo-immunotherapy without anthracycline drugs (like Doxorubicin) is as effective as usual treatment in early-stage triple negative breast cancer. It involves medications such as Paclitaxel, Carboplatin, Cyclophosphamide, Docetaxel, and Pembrolizumab which target different aspects of cancer cell growth.See study design

What are the potential side effects?

Possible side effects include fatigue; hair loss; nausea; low blood counts leading to increased infection risk; nerve damage causing numbness or tingling; allergic reactions; heart problems from some chemotherapy drugs; immune-related issues like inflammation from Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never needed steroids for non-infectious lung inflammation.

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I am 18 years old or older.

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I haven't had severe infections or been hospitalized for one in the last 14 days.

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Both of my breast cancers are negative for ER, PR, and HER2.

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My cancer has not spread to distant parts of my body.

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My heart is strong enough for the trial, with an ejection fraction of 50% or more.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I can provide a specific slide from my initial cancer diagnosis.

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I haven't had a live vaccine in the last 30 days.

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I have not had surgery on the breast currently affected by cancer.

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I haven't had any treatment aimed at curing my current breast cancer.

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I had hepatitis C but am now cured, or I am being treated with undetectable levels.

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My nerve damage symptoms are mild or not present.

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I have not been treated with specific immune therapy drugs before.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My cancer is at a specific stage and has not spread to distant parts of my body.

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I have had a biopsy to check the status of my lymph nodes.

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My breast cancer is triple-negative.

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My breast cancer is not at an advanced stage with significant lymph node involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breast cancer event-free survival (BC-EFS)

Secondary outcome measures

Distant relapse-free interval (DRFI)

Distant relapse-free survival (DRFS)

Incidence of adverse events

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (shorter chemo-immunotherapy)Experimental Treatment7 Interventions

Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

Group II: Arm I (usual chemo-immunotherapy)Active Control9 Interventions

Patients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Surgical Procedure

2020

Completed Phase 2

~160

Biospecimen Collection

2004

Completed Phase 2

~1700

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

262,770 Total Patients Enrolled

54 Trials studying Breast Cancer

65,326 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,924,041 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Priyanka SharmaPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Cyclophosphamide (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05929768 — Phase 3

Breast Cancer Research Study Groups: Arm I (usual chemo-immunotherapy), Arm II (shorter chemo-immunotherapy)

Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05929768 — Phase 3

Cyclophosphamide (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929768 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects have been accepted into this research endeavor?

"Affirmative. Clinicaltrials.gov data verifies that this research endeavor, which was initially advertised on August 23rd 2023, is actively recruiting participants. 2400 people need to be enrolled from one centre in total."

Answered by AI

Is there still an opportunity for people to participate in this clinical research?

"Yes, current information on clinicaltrials.gov confirms that the trial is open to patient recruitment. This trial was first listed on August 23rd 2023 and has undergone subsequent edits up until 8/28/2023."

Answered by AI

Could you describe the potential risks associated with Arm II (shorter chemo-immunotherapy)?

"Arm II's (shorter chemo-immunotherapy) safety is valued at 3 on a 1 to 3 scale, as it has undergone numerous evaluations and data collection procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

2023. "Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05929768.

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