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Cisplatin as First Line Therapy for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker Response

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, June 2007

Sponsors and Collaborators: Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00483223
  Purpose

The purpose of this research study is to :

  • Determine how effective cisplatin is in slowing the time it takes for ER negative, PR negative, HER2 negative breast cancer to progress. Cisplatin is an anti-cancer chemotherapy drug that stops cancer cells from growing abnormally and is used to treat other cancers.
  • Evaluate a new biomarker to help determine which breast cancers are most likely to respond to cisplatin chemotherapy

The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to cisplatin, and that a subgroup of those patients may have a marker in their tumors that predicts response.


Condition Intervention Phase
Breast Cancer
Drug: Cisplatin
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Cisplatin   

U.S. FDA Resources

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 Cisplatin as First Line Therapy for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the objective response rate in patients with ER/PgR/HER2 negative metastatic breast cancer receiving cisplatin as first-line therapy.
  • To evaluate the expression of p63/p73 in primary tumors from this patient cohort as a biomarker to predict response to cisplatin

Secondary Outcome Measures:
  • To determine the progression free survival, clinical benefit rate, and overall survival in patients with triple-negative metastatic breast cancer receiving first line cisplatin therapy
  • To evaluate the safety and toxicity of cisplatin therapy in this patient population.
  • To conduct correlative studies to learn more about the biology of triple negative breast cancer.

Estimated Enrollment:   39
Study Start Date:   June 2007

Detailed Description:

This study is a Phase 2 study designed to evaluate cisplatin as first 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.

  • Participants will be given a cisplatin infusion intravenously on the first day of each treatment cycle. Each treatment cycle will last 3 weeks.
  • During all treatment cycles participants will have a physical exam (including weight and vital signs) and they will be asked general questions about their health and any medications they may be taking, as well as specific questions about any side effects they may be experiencing while receiving study treatment.
  • During every treatment cycle participants will have standard blood tests to check blood counts, liver and kidney function, and a blood marker for you particular type of cancer.
  • CT scans will be taken of the participants tumor every 2 to 3 cycles to assess the response of the tumor to cisplatin.
  • Participants will be in this study for as long as they tolerate the study treatment and their disease does not get any worse.
  • Participants will be required to have a sample of their original tumor sent to Massachusetts General Hospital for correlative studies.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer with stage IV disease, according to AJCC 6th edition, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study
  • All tumors must be ER-, PGR- and HER2-negative
  • 18 years of age or older
  • Paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse
  • Measurable disease by RECIST
  • Performance status of 0,1 or 2 by ECOG criteria
  • Life expectancy greater than 12 weeks
  • Normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol

Exclusion Criteria:

  • Prior chemotherapy for the treatment of recurrent or metastatic breast cancer
  • Prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents
  • Active brain metastases or unevaluated neurological symptoms suggestive of brain metastases
  • Intercurrent illness or other major medical condition or comorbid condition that might affect study participation
  • Significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%
  • Renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe
  • Pregnant or nursing women
  • History or malignancy that was not treated with curative intent
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483223

Contacts
Contact: Steven Isakoff, MD, PhD     617-726-4920     sisakoff@partners.org    
Contact: Karleen Habin     617-726-1922     khabin@partners.org    

Locations
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            

Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute

Investigators
Principal Investigator:     Steven Isakoff, MD, PhD     Massachusetts General Hospital    
  More Information


Mass General Hospital Cancer Center - Breast Oncology Center  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   06-412
First Received:   June 5, 2007
Last Updated:   June 22, 2007
ClinicalTrials.gov Identifier:   NCT00483223
Health Authority:   United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ER negative  
PgR negative  
HER2 negative  
cisplatin  

Study placed in the following topic categories:
Cisplatin
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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