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Sponsors and Collaborators: |
Massachusetts General Hospital Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute North Shore Medical Center |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00483223 |
The purpose of this research study is to :
The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to platinum, and that a subgroup of those patients may have a marker in their tumors that predicts response.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Cisplatin Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response |
Estimated Enrollment: | 82 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Arm: Experimental
Cisplatin or carboplatin (1 arm, 2 cohorts)
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Drug: Cisplatin
Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
Drug: carboplatin
Given intravenously on the first day of each 3-week treatment cycle at AUC6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
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This study is a Phase 2 study designed to evaluate cisplatin/carboplatin as first or second line therapy in metastatic triple negative (ER negative, PR negative, Her2 Negative) breast cancer and to evaluate the expression of p63/p73 as a biomarker to predict response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven Isakoff, MD, PhD | 617-726-4920 | sisakoff@partners.org |
Contact: Karleen Habin | 617-726-1922 | khabin@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Steven Isakoff, MD, PhD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Steven Come, MD | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Erica Mayer, MD | |
North Shore Medical Center | Recruiting |
Peabody, Massachusetts, United States, 01960 | |
Contact: Karen Krag, MD 978-977-3434 | |
Contact: Lisa Fabry 978.977.3434 lfabry@partners.org | |
Principal Investigator: Karen Krag, MD |
Principal Investigator: | Steven Isakoff, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Steven Isakoff, MD, PhD ) |
Study ID Numbers: | 06-412, TBCRC009 |
Study First Received: | June 5, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00483223 |
Health Authority: | United States: Institutional Review Board |
ER negative PgR negative HER2 negative cisplatin |
carboplatinum platinum p63 p73 |
Cisplatin Skin Diseases Breast Neoplasms Carboplatin Breast Diseases |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |