Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT01750073

Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
92 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
Female
Age
19 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may block tumor growth in different ways by targeting certain cells. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the toxicities and tolerability of a neoadjuvant dose-dense regimen cyclophosphamide and paclitaxel with or without trastuzumab/radiation therapy (as clinically indicated) in patients with newly diagnosed stage T1cN0 and II-III breast cancer; followed by maintenance trastuzumab in human epidermal growth factor receptor 2 (HER2) positive OR adriamycin (doxorubicin hydrochloride) followed by radiation therapy (RT) in stage II-III triple negative HER2 (-), estrogen receptor (ER) (-), progesterone receptor (PR) (-) stage T1cN0 and II-III breast cancer patients. II. To determine the pathological complete response rate (pCR) of this treatment regimen. III. To identify possible gene expression profile signatures from whole genome array analysis that correlate with clinical response/resistance to chemotherapy as measured by pathologic complete response rate (pCR). OUTLINE: NEOADJUVANT THERAPY: Patients receive paclitaxel intravenously (IV) over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients with HER2-positive cancer also receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients without metastasis undergo mastectomy or breast conserving surgery 4-8 weeks later. POST-SURGERY/SYSTEMIC THERAPY: HER2-POSITIVE PATIENTS: Patients receive standard radiation therapy. Patients also receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ER/PR POSITIVE PATIENTS: Patients receive standard adjuvant hormonal or endocrine therapy. STAGE T1cN0 TRIPLE NEGATIVE PATIENTS: Patients receive standard radiation therapy. STAGE II-III TRIPLE NEGATIVE PATIENTS: Patients receive doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually thereafter for 5 years.

Conditions

Interventions

TypeNameDescription
DRUGCyclophosphamideGiven IV
DRUGDoxorubicin HydrochlorideGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGPaclitaxelGiven IV
RADIATIONRadiation TherapyUndergo RT
PROCEDURETherapeutic Conventional SurgeryUndergo mastectomy or breast conserving surgery
BIOLOGICALTrastuzumabGiven IV

Timeline

Start date
2012-12-07
Primary completion
2022-05-01
Completion
2026-06-01
First posted
2012-12-17
Last updated
2025-11-18
Results posted
2023-12-20

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01750073. Inclusion in this directory is not an endorsement.