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Trastuzumab for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Senthilkumar Damodaran

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial is testing copanlisib given with trastuzumab and pertuzumab to see if it is effective and has manageable side effects in treating patients with advanced HER2 positive breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events and serious adverse events (Phase Ib)

Incidence of dose limiting toxicities (DLTs) (Phase Ib)

Progression-free survival (PFS) (Phase II)

Secondary outcome measures

Incidence of adverse events and serious adverse events (Phase II)

OS (Phase II)

Overall survival (OS) (Phase Ib)

+1 more

Other outcome measures

Change in expression of genes involved in alternate signaling pathways identified through reverse phase protein array (RPPA) (Phase II)

Change in expression of pharmacodynamics markers downstream of PI3K inhibition (Phase II)

Hormone receptor (HR) status (estrogen receptor [ER] and progesterone receptor [PR]) (Phase II)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase I, Phase II Arm I (copanlisib, trastuzumab, pertuzumab)Experimental Treatment3 Interventions

Patients receive copanlisib IV over 60 minutes on days 1 and 8. Patients also receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Phase II Arm II (trastuzumab, pertuzumab)Active Control2 Interventions

Patients receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Pertuzumab

2014

Completed Phase 3

~7500

Copanlisib

2016

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,703 Previous Clinical Trials

40,931,748 Total Patients Enrolled

942 Trials studying Breast Cancer

1,543,966 Patients Enrolled for Breast Cancer

Senthilkumar DamodaranPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

5 Previous Clinical Trials

1,185 Total Patients Enrolled

Frequently Asked Questions

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

How many participants have registered for this clinical study?

"Affirmative, according to the data hosted by clinicaltrials.gov this experiment commenced on December 6th 2019 and is still actively enrolling candidates. 12 participants need to be admitted from two separate sites."

Answered by AI

Are there any vacancies from the research study still available for potential participants?

"Affirmative. Clinicaltrials.gov records verify that this medical trial was initially advertised on December 6th 2019 and has been continuously updated since then. Currently, 12 patients are being sought from two distinct sites for the study to progress."

Answered by AI

What other experiments have employed Trastuzumab to assess its efficacy?

"Trastuzumab was initially trialed in 1999 at Ospedale di Circolo e Fondazione Macchi. Since then, 392 studies have been completed and there are currently 224 active experiments recruiting participants, many of which occur around Houston, Texas."

Answered by AI

To what diseases is Trastuzumab routinely prescribed?

"Trastuzumab is frequently prescribed to treat brca1 gene mutations, however it has also been used for therapeutic procedure, inflammatory breast cancer (IBC), and general cases of breast malignancy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer

2021. "Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04108858.