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

This study has been completed.
Sponsor:
Collaborators:
Amgen
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591851
First received: December 26, 2007
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • cardiac saftey [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    LEVF by Muga scan


Secondary Outcome Measures:
  • Toxicity, time to recurrence, overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    CTC v.3.0


Enrollment: 70
Study Start Date: December 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
single arm study
Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
No Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591851

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Amgen
Genentech, Inc.
Investigators
Principal Investigator: Chau Dang, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00591851     History of Changes
Other Study ID Numbers: 04-126
Study First Received: December 26, 2007
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
breast cancer
adenocarcinoma of the breast
cardiac safety
Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Paclitaxel
Trastuzumab
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014