HER2 Positive Breast CarcinomaPhase 2NCT02654119
Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery
A Phase 2 study testing Cyclophosphamide, Laboratory Biomarker Analysis and Paclitaxel in people with HER2 Positive Breast Carcinoma and Stage I Breast Cancer AJCC v7, run by University of Nebraska at 3 sites in United States.
Trial summary
This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- HER2 Positive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
- What is being tested?
- Cyclophosphamide, Laboratory Biomarker Analysis and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2015to 8 Dec 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer
- Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Within 30 days prior to enrollment: Absolute neutrophil count greater than or equal to 1,500/mcl
- Within 30 days prior to enrollment: Platelet count equal to or greater than 150,000/mcl
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- Within 30 days prior to enrollment: Hemoglobin > 11 gm/dl
- Within 30 days prior to enrollment: Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)
- Within 30 days prior to enrollment: Total bilirubin equal to or less than 1.5 times the ULN
- Within 30 days prior to enrollment: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN
- Within 30 days prior to enrollment: Creatinine less than 1.5 times the ULN
- Able to give informed consent
- All included subjects must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram
- Able to return for treatment and follow-up on the specified days
Who cannot join
- Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
- Subjects with pre-existing grade II peripheral neuropathy
- History of previous chemotherapy
- Stage IV or metastatic breast cancer
- Pregnant or nursing women
- Inability to cooperate with treatment protocol
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- No active serious infections or other conditions precluding chemotherapy
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.
- Known hypersensitivity to any component of required drugs in the study
- Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiographic (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Faith Regional Health Services Carson Cancer Center
Norfolk, Nebraska, 68701
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients
This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the toxicities and ability to complete the planned treatment of a dose-dense regimen of cyclophosphamide and paclitaxel with trastuzumab in subjects with newly diagnosed stage I-II HER2/neu positive breast cancer.
II. To estimate recurrence free survival of a dose-dense regimen of cyclophosphamide and paclitaxel with trastuzumab in subjects with newly diagnosed stage I-II HER2/neu positive breast cancer.
OUTLINE:
SYSTEMIC THERAPY: Patients receive cyclophosphamide intravenously (IV) over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard National Comprehensive Care Network (NCCN) guidelines.
After completion of study treatment, patients are followed up every 3 months for 2 years.
- Conditions
- HER2 Positive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7
- Being tested
- Cyclophosphamide, Laboratory Biomarker Analysis, Paclitaxel, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
TrastuzumabBiological
Also called ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cyclophosphamide, paclitaxel, trastuzumab) | Experimental | SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines. Receives: Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Neutropenia
Number of participants who experienced treatment-emergent neutropenia graded according to National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03.
Measured: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).
Number of Participants With Paclitaxel-related Neuropathy
Number of Participants who experienced paclitaxel-related neuropathy graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Measured: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).
Number of Participants With Cardiotoxicity Grade 3/4 Cardiotoxicity, Graded According to the NCI CTCAE v4.03
Number of Participants who experienced grade 3/4 cardiotoxicity with standard treatment, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Measured: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).
Number of Participants With Grade 3/4 Nausea/Vomiting, Graded According to the NCI CTCAE v4.03
Participants that experienced grade 3/4 nausea/vomiting with this regimen when compared to standard regimens.
Measured: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).
Number of Participants With Recurrence Free Survival (RFS)
RFS and survival curves will be plotted following the method of Kaplan and Meier using the full analysis set.
Measured: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed at 2 years
Number of Participants With Inability to Complete Treatment, Defined as a Patient That Requires a Lower Dose of Therapy (Defined as Dose Lowered by 50%), or a Postponement of Scheduled Treatment of Longer Than 28 Days, or Discontinuation for Any Reason
Number of participants with inability to complete treatment, defined as a patient that requires a lower dose of therapy (defined as dose lowered by 50%), or a postponement of scheduled treatment of longer than 28 days, or discontinuation of treatment for any reason. will be described using frequencies and proportions and 90% confidence intervals.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start11 Dec 2015
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER2 Positive Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amulya Yellala, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654119
- Sponsor's protocol ID
- 0318-15-FB
- Other IDs
- NCI-2015-01879, P30CA036727
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2016
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No