← Back to Search

Chemotherapy

Chemotherapy +/− Trastuzumab for Breast Cancer

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

Must not have

History of any noninvasive (in situ) breast carcinoma within the past 5 years

Prior radiotherapy to the chest wall

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had a non-spreading breast cancer diagnosis within the last 5 years.

Select...

I have had radiation therapy to my chest before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Count of Patients With Pathologic Complete Response (pCR)

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

Secondary study objectives

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

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 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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