Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer
This study has been completed.
Sponsor:
Harold J. Burstein, MD, PhD
Collaborators:
Celgene Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00308178
First received: March 28, 2006
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Abraxane |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose Dense AB1-007 (Abraxane) in Adjuvant Chemotherapy for Breast Cancer: A Feasibility Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- to evaluate quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | March 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Abraxane
Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks)
- Patients will receive regular chemotherapy every 2 weeks for up to 8 cycles (approximately 16 weeks total)of treatment. During the first four cycles patients will be treated with Adriamycin and Cytoxan, and for the second four cycles they will be treated with Abraxane.
- Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy. During the last four cycles (while the patient is taking Abraxane) they will not receive G-CSF unless they have low blood counts.
- If the patient has HER-2 positive breast cancer, they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane (after 4 cycles of adriamycin and cytoxan treatment).
- This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment, then again at 2 months, 4 months, 6 months, and 1 year after starting study treatment.
- The following tests and procedures will be performed at the time periods specified. Cycle 1-4 Day 1: Physical exam, vital signs, and blood tests. Cycle 5 Day 1: Physical exam, vital signs, blood tests, RVG (measurement of heart function) and questionnaire. Cycle 6 & 7 Day 1: Physical exam, vital signs, and blood tests. Cycle 8 Day 1: physical exam, vital signs, blood tests, questionnaire. Follow-up (6 months and 1 year after cycle 1 day 1): questionnaire.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed breast cancer, with clinical stage I, II, or III disease
- Must register at the beginning of adjuvant or neoadjuvant chemotherapy
- 18 years of age or older
- ECOG performance status of 0 or 1
- Normal organ and marrow function
Exclusion Criteria:
- Previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason
- Pregnant or nursing
- Receiving any other investigational agents
- Patients with Stage IV breast cancer
- Current grade II or greater peripheral neuropathy or prior history of grade II or greater neuropathy
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Immune deficiency when treated with marrow-suppressive therapy or HIV-positive patients receiving anti-retroviral therapy
- Patients with sickle cell disease
- Known history of hyperviscosity syndrome
- Patients on lithium
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308178
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massacusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Harold J. Burstein, MD, PhD
Celgene Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
| Principal Investigator: | Harold Burstein, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Harold J. Burstein, MD, PhD, Associate Professor of Medicine, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00308178 History of Changes |
| Other Study ID Numbers: | 05-249 |
| Study First Received: | March 28, 2006 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Abraxane dose-dense chemotherapy taxol |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Paclitaxel Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013