Clinical Trial: NCT02654119 - My Cancer Genome

NCT02654119

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02654119

Trial Eligibility

Document

Title

Brief Title: Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Patients With Stage I-II HER2/Neu Positive Breast Cancer After Surgery
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

Clinical Trial IDs

ORG STUDY ID: 318-15
SECONDARY ID: NCI-2015-01879
SECONDARY ID: 318-15
SECONDARY ID: P30CA036727
NCT ID: NCT02654119

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
Stage IIB Breast Cancer AJCC v6 and v7

Interventions

Drug	Synonyms	Arms
Cyclophosphamide	(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719	Treatment (cyclophosphamide, paclitaxel, trastuzumab)
Paclitaxel	Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat	Treatment (cyclophosphamide, paclitaxel, trastuzumab)
Trastuzumab	ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar PF-05280014, Trastuzumab-dkst	Treatment (cyclophosphamide, paclitaxel, trastuzumab)

Purpose

Detailed Description

      PRIMARY OBJECTIVES:

      I. 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.

Trial Arms

Name	Type	Description	Interventions
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.	Cyclophosphamide Paclitaxel Trastuzumab

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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

        Exclusion Criteria:

          -  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

          -  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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	20 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Incidence of neutropenia, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03
Time Frame:	Up to 3 months after final chemotherapy treatment (including trastuzumab)
Safety Issue:
Description:	The incidence rates of neutropenia and adverse events will be summarized using frequencies, percentages and 90% confidence intervals. Adverse events will be described by cycle. The frequency of toxicity, categorized by toxicity grades, will be summarized.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	University of Nebraska

Last Updated

September 4, 2020

Clinical Trials /

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Patients With Stage I-II HER2/Neu Positive Breast Cancer After Surgery