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

NCT02654119 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 0318-15-FBNCI-2015-01879P30CA036727
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (6)

• Number Participants With Neutropenia, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4.03

  Number of participants who experienced Neutropenia.

  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, Graded According to the NCI CTCAE v4.03

  Number of Participants experienced paclitaxel-related neuropathy and adverse events

  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

  Participants experienced grade 3/4 cardiotoxicity with standard treatment

  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.

  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.

  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.

  Up to 2 years

Study Arms (1)

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.

Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Trastuzumab

Interventions

Cyclophosphamide DRUG

Given IV

Also known as: (-)-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)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (cyclophosphamide, paclitaxel, trastuzumab)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (cyclophosphamide, paclitaxel, trastuzumab)

Trastuzumab BIOLOGICAL

Given IV

Also known as: 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)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Faith Regional Health Services Carson Cancer Center

Norfolk, Nebraska, 68701, United States

Location

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Paclitaxel; Taxes; Trastuzumab; PF-05280014; Ogivri

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Amulya Yellala
• Organization: University of Nebraska Medical Center

amulya.yellala@unmc.edu

402-559-5388

Study Officials

• Amulya Yellala, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: December 11, 2015
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2025-12

Locations

US (3)