Your session is about to expire
← Back to Search
Alkylating agents
Chemotherapy +/− Trastuzumab for Breast Cancer
Phase 2
Waitlist Available
Led By Amulya Yellala
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with histologically proven invasive breast cancer without distant metastases; a clinical tumor size of at least 1 cm with or without evidence of positive nodes
Patient's awareness of the neoplastic nature of the disease and provision of written, informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing paclitaxel and cyclophosphamide with or without trastuzumab before surgery to see if it can reduce the amount of normal tissue that needs to be removed in patients with previously untreated breast cancer.
Who is the study for?
This trial is for women with invasive breast cancer without distant metastases, a tumor size of at least 1 cm, and no severe illnesses that would prevent consent. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and can't have had certain prior treatments or other cancers.Check my eligibility
What is being tested?
The study tests how well paclitaxel and cyclophosphamide chemotherapy work with or without trastuzumab (a monoclonal antibody) before surgery in patients with untreated breast cancer. The goal is to shrink the tumor and limit surgery to remove less tissue.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of drugs like trastuzumab, blood cell count changes due to chemotherapy agents such as paclitaxel and cyclophosphamide, fatigue, nausea, risk of infection increase, heart problems related to trastuzumab therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with breast cancer that has not spread far and my tumor is at least 1 cm big.
Select...
I understand my cancer diagnosis and have given written consent for treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My heart pumps well and has normal movement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR)
Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Secondary outcome measures
Clinical Complete Response
Failure-free Survival (FFS)
Identification of Gene Expression Profile Signatures That Correlate With Clinical Response as Measured by pCR
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, surgery, post-operative therapy)Experimental Treatment7 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Paclitaxel
2011
Completed Phase 4
~5380
Radiation Therapy
2017
Completed Phase 3
~7250
Trastuzumab
2014
Completed Phase 4
~5190
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
541 Previous Clinical Trials
1,144,661 Total Patients Enrolled
15 Trials studying Breast Cancer
1,006,302 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,272 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Amulya YellalaPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unmanaged ongoing illnesses.I have had cancer before, but it was either skin cancer treated successfully or a non-spreading type that was treated.I haven't had a heart attack in the last 6 months and don't have severe heart issues.You have at least one spot that can be measured using a mammogram, ultrasound, or MRI.Your alkaline phosphatase level is not more than 1.5 times the normal limit.I am a woman with breast cancer that has not spread far and my tumor is at least 1 cm big.Your platelet count is at least 150,000 per microliter.I understand my cancer diagnosis and have given written consent for treatment.I am a woman who can have children and have a recent negative pregnancy test.I cannot have surgery.I am unable to follow the treatment plan as required.I have HIV, hepatitis, or liver problems.I am fully active or restricted in physically strenuous activity but can do light work.Your absolute neutrophil count is at least 1,500 per microliter.My breast cancer is inflammatory, stage IV, or has spread to other parts.Your total bilirubin level in the blood is no more than 1.5 times the upper limit of normal.I have moderate numbness, pain, or tingling in my hands or feet.My heart pumps well and has normal movement.Your liver enzyme levels (AST and ALT) are not more than 1.5 times the upper limit of normal.I have had chemotherapy or hormone therapy for breast cancer or another type of cancer.Your kidney function, measured by creatinine, is within a certain normal range.I had radiation over 5 years ago for cancer other than breast cancer and have no signs of another cancer now.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, surgery, post-operative therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger