CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled / 92 target
Drug / intervention
Cyclophosphamide +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01750073
NCT01750073Phase 2CompletedMonitor (0.6/mo)Completion was 50mo ago
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A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer

University of Nebraska·interventional·Posted Dec 17, 2012·Updated Jun 26, 2026

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Doxorubicin Hydrochloride, and 5 other interventions for Estrogen Receptor Negative and 15 related conditions. Completed, enrolled 92 participants across 4 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive, Invasive Breast Carcinoma, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IA Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartDec 7, 2012
Primary CompletionMay 1, 2022
Study CompletionNov 24, 2025
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 13.5 years ago

Arms & Interventions

Treatment (chemotherapy, surgery, post-operative therapy)experimental

See Detailed Description

Drug: CyclophosphamideDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelRadiation: Radiation TherapyProcedure: Therapeutic Conventional SurgeryBiological: Trastuzumab

Interventions

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Radiation Therapyradiation

Undergo RT

Therapeutic Conventional Surgeryprocedure

Undergo mastectomy or breast conserving surgery

Trastuzumabbiological

Given IV