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Sponsors and Collaborators: |
Duke University Genentech |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00479674 |
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal antibodies including bevacizumab target VEGF to reduce angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Abraxane Drug: Bevacizumab Drug: Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Anthracycline-based chemotherapy is widely used as adjuvant treatment for breast cancer. In addition to the challenge posed by anthracycline-induced cardiotoxicity, there are issues surrounding previous treatment with anthracyclines which limit its utility in the metastatic disease setting. Many patients with advanced disease will have had prior anthracycline-based adjuvant therapy, may have reached a maximum cumulative lifetime dose, or developed refractory disease, creating an obvious need for non-anthracycline treatment strategies.3 Platinum- and taxane-based chemotherapies as first-line therapy for metastatic breast cancer have demonstrated significant activity, producing single-agent response rates > 50%; in combination these rates increased to > 60% in both previously untreated and in patients who previously received anthracyclines.3 However, overall survival has remained relatively unchanged.4 As there is currently no standard of care for patients with metastatic breast cancer, various physical and psychological factors must be considered when evaluating chemotherapy treatment options, including the patient's tumor biology and growth rate, presence and extent of metastases, history of prior treatment and response, sensitivity and tolerance to therapy, and quality of life.2 Strategies to develop combination, higher dose, or sequential regimens using these active agents, while improving response rates and/or time to progression, may produce increased toxicity without increased survival.2 Because metastatic breast cancer remains essentially incurable using cytotoxic therapy alone, the study of targeted biologics offers new opportunities to enhance drug delivery via their ability to regulate specific receptors that are associated with clinically aggressive disease processes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory tests performed within 14 days of study entry:
Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN;
No reproductive potential:
Exclusion Criteria:
Contact: Kathryn Clarke, BSN | 919-668-3810 | kathryn.clarke@duke.edu |
Contact: Kimberly Blackwell, MD | 919-668-1748 | kimberly.blackwell@duke.edu |
United States, Florida | |
Palm Beach Cancer Center Institute | Recruiting |
West Palm Beach, Florida, United States, 33401-3406 | |
Contact: Karen Minder, BSN 561-366-4128 karen.minder@pbcancer.com | |
Contact: Elisabeth McKeen, MD 561-366-4151 elisabeth.mckeen@pbcancer.com | |
Principal Investigator: Elisabeth McKeen, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Kimberly Blackwell, MD 919-668-1748 kimberly.blackwell@duke.edu | |
Contact: Kathryn Clarke, BSN 919-3810 kathryn.clarke@duke.edu | |
Principal Investigator: Kimberly Blackwell, MD | |
Moses Cone Regional Cancer Center | Not yet recruiting |
Greensboro, North Carolina, United States, 27403 | |
Contact: Peter Rubin, MD 336-832-1100 peter.rubin@mosescone.com | |
Contact: Vivian Sheidler, BSN 336-832-0836 vivian.sheidler@mosescone.com | |
Principal Investigator: Peter Rubin, MD | |
Forsyth Regional Cancer Center | Not yet recruiting |
Winston-Salem, North Carolina, United States, 27103-3019 | |
Contact: Elizabeth White 336-718-8461 ecwhite@novanthealth.org | |
Contact: Julie Jester, BSAH 336-718-8491 jmjester@novanthealth.org | |
Principal Investigator: Judith Hopkins, MD | |
Presbyterian Health Care | Not yet recruiting |
Charlotte, North Carolina, United States, 28204 | |
Contact: Jami Linn, BSN 704-384-8823 jalinn@novanthelath.org | |
Principal Investigator: Richard Reiling, MD | |
Northeast Oncology Associates | Not yet recruiting |
Concord, North Carolina, United States, 28205 | |
Contact: Sheri Broshahan, BSN 704-783-1520 sbrosnahan@northeastmedical.org | |
Principal Investigator: Garry Schwartz, MD | |
United States, South Carolina | |
South Carolina Oncology Associates | Not yet recruiting |
Columbia, South Carolina, United States, 29210 | |
Contact: Jennifer Peelman, BS 803-461-3095 jjpeelman@sconcology.net | |
Principal Investigator: Rosemary Lambert-Falls, MD | |
United States, Virginia | |
Viginia Oncology Associates | Not yet recruiting |
Newport News, Virginia, United States, 23606-4209 | |
Contact: Elizabeth Harding, MD 757-873-9400 elizabeth.harden@usoncology.com |
Principal Investigator: | Kimberly Blackwell, MD | Duke University |
Study ID Numbers: | DCRO_BR_2006_01 |
Study First Received: | May 25, 2007 |
Last Updated: | June 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00479674 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic Breast Cancer Advanced Breast Cancer Hormone Receptor AND Her2/neu Negative |
Triple Negative Triple Negative Breast Cancer Stage IV or Inoperable Stage III Breast Cancer |
Estrogens Skin Diseases Progesterone Breast Neoplasms Bevacizumab Carboplatin Antimitotic Agents |
Hormones Angiogenesis Inhibitors Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Breast Neoplasms Bevacizumab Carboplatin Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Breast Diseases |