Trastuzumab for Breast Cancer

University of Oklahoma Health Sciences Center, Oklahoma City, OK
Targeting 3 different conditionsTrastuzumab +2 morePhase 1 & 2RecruitingLed by Senthilkumar DamodaranResearch Sponsored by National Cancer Institute (NCI)

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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For Phase 1B, you can have received any number of treatments for metastatic cancer as long as you are able to tolerate trastuzumab and pertuzumab. For Phase 2, you should have only received first line of chemotherapy treatment (taxane) with trastuzumab and pertuzumab for metastatic cancer.

Timeline

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
FDA approved
Pertuzumab
FDA approved
Copanlisib
FDA approved

Find a site

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,402 Previous Clinical Trials
41,225,329 Total Patients Enrolled
930 Trials studying Breast Cancer
1,540,025 Patients Enrolled for Breast Cancer
Senthilkumar DamodaranPrincipal Investigator
University of Texas MD Anderson Cancer Center LAO
5 Previous Clinical Trials
1,305 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](https://www.withpower.com/clinical-trials/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
2019. "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.
~3 spots leftby Sep 2024
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