Clinical trial · Interventional
Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back. The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- single arm study
- interventionNames
- Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
Primary outcomes (1)
- measure
- Cardiac Saftey
- timeFrame
- Baseline-18 months
- description
- LVEF by Muga scan
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adenocarcinoma breast cancer * ECOG performance status of 0 or 1 * peripheral neuropathy less than or equal to 1 * discontinued hormonal therapy as a chemoprevention while onstudy * LVEF by MUGA \> 55%? * Absolute neutrophil count (ANC)\> 1000/µL) * platelet count \> 100,000/µL) * SGOT OR SGPT \< 92.5 units/L Exclusion Criteria: * Stage IV breast cancer * any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer * pregnant or lactating patients * active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer * previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL? * unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months * psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements? * active, unresolved infections * sensitivity to E. coli derived proteins * prior chemotherapy with an anthracycline * prior Herceptin therapy
References
Publications (0)
Data not yet available