OB/GYN & Women's Health
PHASE2
● Phase II
Phase II trial of cyclophosphamide, paclitaxel, trastuzumab in stage I-II HER2+ breast cancer completes with 20 patients
ClinicalTrials.gov
Published March 30, 2026
University of Nebraska
NCT02654119 ↗
This completed phase II trial investigated the side effects and efficacy of a dose-dense regimen of cyclophosphamide, paclitaxel, and trastuzumab administered after surgery in patients with newly diagnosed stage I-II HER2/neu positive breast cancer. The study enrolled 20 patients. The primary objectives were to determine the toxicities and ability to complete the planned treatment, and to estimate recurrence-free survival. The systemic therapy regimen consisted of cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1, repeated every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Maintenance trastuzumab therapy began in course 6. The primary outcomes measured were the number of participants with neutropenia, paclitaxel-related neuropathy, and grade 3/4 cardiotoxicity, all graded according to the NCI CTCAE v4.03. The study started on 2015-12-11, with primary completion on 2025-12-08, and results were posted on 2026-03-23. The abstract does not provide specific numerical results for the primary outcomes, recurrence-free survival estimates, or completion rates.
After surgery for early-stage HER2-positive breast cancer, many women face months of chemotherapy to try to prevent the cancer from returning. This study asked a practical question: could a more intense, shorter schedule of treatment be both tolerable and effective? The trial tested a specific three-drug combination—cyclophosphamide, paclitaxel, and trastuzumab (Herceptin)—given every two weeks for six cycles, followed by continued trastuzumab alone. The main goals were straightforward: to see what side effects emerged, whether patients could finish the planned treatment, and to get an early estimate of whether the cancer stayed away (recurrence-free survival). The study was small, enrolling 20 patients, and focused on tracking specific side effects like neutropenia (low white blood cell count), nerve damage from paclitaxel, and potential heart issues from trastuzumab. The results provide initial data on the feasibility of this dose-dense approach for this group of patients, offering a snapshot of what treatment might look like on a compressed timeline.
What this means for you: A shorter, intense chemo schedule was tested for early HER2+ breast cancer to see if it was manageable and kept the cancer from returning.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): 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
Intervention(s): Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Trastuzumab (BIOLOGICAL)
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.
Detailed: 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
Primary Outcome(s): 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 With Paclitaxel-related Neuropathy, Graded According to the NCI CTCAE v4.03; Number of Participants With Cardiotoxicity Grade 3/4 Cardiotoxicity, Graded According to the NCI CTCAE v4.03
Enrollment: 20 (ACTUAL)
Lead Sponsor: University of Nebraska
Start: 2015-12-11 | Primary Completion: 2025-12-08
Results posted: 2026-03-23