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Chemotherapy

Chemotherapy +/− Trastuzumab for Breast Cancer

Q: Would I be a suitable candidate for participation in this medical experiment?

To qualify for the trial, applicants must have <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and be between 18-120 years old. 105 individuals are being sought to participate in the research.

Q: What kind of adverse effects can be incurred from trastuzumab utilization?

Trastuzumab has had some clinical trials to establish its safety, so it was given a score of 2. There is no current data showing efficacy for this drug yet.

Q: What maladies can trastuzumab effectively ameliorate?

Trastuzumab is a commonly prescribed drug for treating <a href="https://www.withpower.com/clinical-trials/esophageal-cancer">esophageal cancer</a>, and it has also been used to address <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a>, and various head-related ailments.

Q: Are senior citizens able to partake in this clinical investigation?

This clinical trial requires that participants are between 18 and 120 years of age. There is a total of 4835 trials for patients outside this range, including 416 dedicated to those under 18 and 4419 for seniors above 65.

Q: Are there any vacant spots available for this study's participants?

According to clinicaltrials.gov, this medical experiment is not actively recruiting participants at this moment in time. Upon first being posted on September 14th 2005 and last updated on January 5th 2021, the trial has since been closed off. Nonetheless, 4756 other trials are accepting applicants presently.

Q: Does this trial represent a unique contribution to clinical research?

According to the data available, there are 2153 active trials for trastuzumab situated within 86 countries and 4292 cities. The first of such experiments commenced in 1997 with Alfacell as its sponsor; this trial tested 300 participants during Phase 3 drug approval. Following that initial experiment 3607 more have been conducted since then.

Q: Could you elucidate what the upper boundary of participants is for this clinical experiment?

This trial is not presently taking in new patients, having been originally posted on September 14th 2005 and most recently updated on January 5th 2021. Alternatively, there are 2603 studies involving <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and 2153 trials using trastuzumab that are actively accepting enrollees.

Q: Could you please elucidate on the past investigations that have been conducted involving trastuzumab?

At this time, there are 2153 ongoing clinical trials investigating trastuzumab with 537 studies in Phase 3. Although Seattle is an important site for these experiments, the drug's research network spans 102076 other locations.

Phase 2

Waitlist Available

Led By Joanne Mortimer, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Inflammatory breast cancer allowed

ECOG performance status < 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post treatment

Awards & highlights

Study Summary

This trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

Who is the study for?

This trial is for adults with stage II or III breast cancer, who have not had chest radiotherapy or other cancers in the past 5 years. They must have good organ function and performance status, no significant neuropathy, and if fertile, agree to use nonhormonal contraception.Check my eligibility

What is being tested?

The study is testing how well combination chemotherapy works with or without trastuzumab (a monoclonal antibody) in shrinking tumors before surgery. Patients are randomly assigned to receive either just chemo or chemo plus trastuzumab.See study design

What are the potential side effects?

Chemotherapy drugs may cause nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts. Trastuzumab can lead to heart problems and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have inflammatory breast cancer.

Select...

I can do most of my daily activities without help.

Select...

My breast cancer is either ductal or lobular type.

Select...

My condition is at stage II or III.

Select...

I do not have significant nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Count of Patients With Pathologic Complete Response (pCR)

Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.

Secondary outcome measures

Quality of life and neuropathy assessment of prognostic and predictive markers as measured by FACT exploratory methods at 1 year

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumabExperimental Treatment5 Interventions

Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Group II: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and CarboplatinExperimental Treatment4 Interventions

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.

Group III: Docetaxel, Doxorubicin Hydrochloride, and CyclophosphamideActive Control3 Interventions

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Doxorubicin

FDA approved

Trastuzumab

2014

Completed Phase 4

~5190

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,339 Total Patients Enrolled

42 Trials studying Breast Cancer

6,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,032 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,239 Patients Enrolled for Breast Cancer

Joanne Mortimer, MDPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

632 Total Patients Enrolled

1 Trials studying Breast Cancer

500 Patients Enrolled for Breast Cancer

Media Library

Carboplatin, Paclitaxel, Docetaxel, Cyclophosphamide, Doxorubicin Hydrochloride (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00295893 — Phase 2

Breast Cancer Research Study Groups: Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide, Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin, Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab

Breast Cancer Clinical Trial 2023: Carboplatin, Paclitaxel, Docetaxel, Cyclophosphamide, Doxorubicin Hydrochloride Highlights & Side Effects. Trial Name: NCT00295893 — Phase 2

Carboplatin, Paclitaxel, Docetaxel, Cyclophosphamide, Doxorubicin Hydrochloride (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00295893 — Phase 2

Frequently Asked Questions

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

Would I be a suitable candidate for participation in this medical experiment?

"To qualify for the trial, applicants must have breast cancer and be between 18-120 years old. 105 individuals are being sought to participate in the research."

Answered by AI

What kind of adverse effects can be incurred from trastuzumab utilization?

"Trastuzumab has had some clinical trials to establish its safety, so it was given a score of 2. There is no current data showing efficacy for this drug yet."

Answered by AI

What maladies can trastuzumab effectively ameliorate?

"Trastuzumab is a commonly prescribed drug for treating esophageal cancer, and it has also been used to address lymphoma, acute lymphoblastic leukemia, and various head-related ailments."

Answered by AI

Are senior citizens able to partake in this clinical investigation?

"This clinical trial requires that participants are between 18 and 120 years of age. There is a total of 4835 trials for patients outside this range, including 416 dedicated to those under 18 and 4419 for seniors above 65."

Answered by AI

Are there any vacant spots available for this study's participants?

"According to clinicaltrials.gov, this medical experiment is not actively recruiting participants at this moment in time. Upon first being posted on September 14th 2005 and last updated on January 5th 2021, the trial has since been closed off. Nonetheless, 4756 other trials are accepting applicants presently."

Answered by AI

Does this trial represent a unique contribution to clinical research?

"According to the data available, there are 2153 active trials for trastuzumab situated within 86 countries and 4292 cities. The first of such experiments commenced in 1997 with Alfacell as its sponsor; this trial tested 300 participants during Phase 3 drug approval. Following that initial experiment 3607 more have been conducted since then."

Answered by AI

Could you elucidate what the upper boundary of participants is for this clinical experiment?

"This trial is not presently taking in new patients, having been originally posted on September 14th 2005 and most recently updated on January 5th 2021. Alternatively, there are 2603 studies involving breast cancer and 2153 trials using trastuzumab that are actively accepting enrollees."

Answered by AI

Could you please elucidate on the past investigations that have been conducted involving trastuzumab?

"At this time, there are 2153 ongoing clinical trials investigating trastuzumab with 537 studies in Phase 3. Although Seattle is an important site for these experiments, the drug's research network spans 102076 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

2005. "Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00295893.

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