Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

NCT00591851 | Completed Phase 2 Results DMC

• 1 other identifier: 04-126
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

breast cancer; adenocarcinoma of the breast; cardiac safety; Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Cardiac Saftey

  LVEF by Muga scan

  Baseline-18 months

Study Arms (1)

1

EXPERIMENTAL

single arm study

Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)

Interventions

AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) DRUG

AC \[Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)\] Followed By Paclitaxel (P)

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Amgen: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Chau Dang
• Organization: Memorial Sloan-Kettering Cancer Center

dangc@mskcc.org

914-367-7181

Study Officials

• Chau Dang, MD

  Memorial Sloan Kettering Cancer Center

  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: December 26, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 25, 2023
• Results First Posted: December 1, 2014

Record last verified: 2023-09

Locations

US (1)