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Research & Clinical Trials > Study Search Tool > Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa (Inform)

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Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa (Inform)

This study is open to:

People diagnosed with invasive breast cancer and the following:

  • Tumor that is greater than 1.5 cm in size
  • Stage 1, 2 or 3 
  • HER2 negative
  • ER/PR positive of negative (ER positive patients are allowed if physician has determined neoadjuvant chemo is appropriate).
  • Use of an effective means of contraception is required
This study is not open to:

Patients are excluded if they:

  • are pregnant or breastfeeding
  • have had prior chemotherapy at any time
  • have had prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
  • have breast cancer recurrence on same side as original cancer, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
  • have peripheral neuropathy from any cause that exceeds grade 1
  • have significant hearing loss
  • have kidney dysfunction
  • Uncontrolled condition or illness
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa (Inform)

INFORM - Chemotherapy in BRCA-associated Breast Cancer

Clinicaltrials.gov identifier:
NCT01670500

Treatment:
Breast

Study Contact Information

Study Sites

This study is open in multiple sites in Colorado, Connecticut, Washington, DC, Maryland, Massachusetts, New Jersey, North Carolina, Rhode Island, and Texas. 

About the Study

INFORM is a study for patients newly diagnosed with breast cancer who have a BRCA1 or BRCA2 mutation. The study is evaluating whether the chemotherapy drug Cisplatin is better than currently used standard chemotherapy drugs (Cyclophosphamide/Doxorubicin) for treating patients with newly diagnosed breast cancer due to an inherited mutation in BRCA1 or BRCA2

This is a neoadjuvant study which means that patients will receive the chemotherapy before having surgery to remove the remaining tumor. Only patients who have not had their breast cancer tumor removed yet will be eligible for this study. 

Type of Study: 

This is a randomized, open-label, 2-arm treatment study.

  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither you nor the research doctor will choose what group you will be in. You will have an equal chance of being placed in either group. 
  • The study has two arms. This means that patients in the study are placed in one of two different groups.
  • The study is open-label. This means that although participants will be randomly selected to receive one of two treatments, they will know which treatment they are receiving while participating in the study. 

What the Study Entails

  • Patients placed in the cisplatin group will receive cisplatin once every three weeks for a total of four doses.
  • Patients placed in the "AC" chemotherapy will receive both doxorubicin and cyclophosphamide once every 2 or 3 weeks for a total of four doses by vein on the first day of each treatment cycle. 
  • All patients in the study will have surgery to remove the tumor within six weeks after their last dose of chemotherapy. 

Study Lead Investigator

Principal Investigator: Nadine Tung, MD

Contact information: Phone: (617)667-7081 ntung@bidmc.harvard.edu

Study Sites

  • Colorado, Aurora: University of Colorado Cancer Center
    • Contact: Virginia Borges, MD by phone: 303-724-0186 or email
  • Connecticut, Derby: Smilow Cancer Hospital Care Center
    • Contact: Erin Hofstatter, MD by email
  • Connecticut, Guilford: Smilow Cancer Hospital Care Center
    • Contact: Erin Hofstatter, MD by email 
  • Connecticut, Hartford: St. Francis Hospital and Medical Center
  • Washington, DC: Georgetown University Medical Center
    • Contact: Claudine Isaacs, MD by email 
  • Washington, DC: Sibley Memorial Hospital
    • Contact: Antonio Wolff, MD by email
  • Maryland, Baltimore: Jonhs Hopkins
    • Contact: Antonio Wolff, MD by email
  • Massachusetts, Boston: Massachusetts General Hospital
    • Contact: Steven Isakoff, MD, PhD by phone: 617-726-4920 or by email 
  • Massachusetts, Boston: Beth Israel Deaconess
    • Contact: Nadine Tung, MD by phone: 617-667-7081 or by email 
  • Massachusetts, Boston: Dana Farber Cancer Institute
    • Contact: Judy Garber, MD, MPH by phone: 617-632-2282 or by email 
  • New Jersey, New Brunswick: Rutgers Cancer Institute of New Jersey
    • Contact: Deborah Toppmeyer, MD by phone: 732-235-6789 or by email​ 
  • North Carolina, Durham: Duke University
    • Contact: P. Kelly Marcom by email
  • Rhode Island, Providence: Women and Infants Hospital
    • Contact: Robert Legare, MD by phone: 401-453-7540 or by email
  • ​Texas, Houston: MD Anderson Cancer Center 
    • Contact: Banu Arun, MD by phone: 713-792-2817 or by email
  • Texas, Katy: MD Anderson in Katy
    • Contact: Banu Arun, MD by email
  • ​Texas, Nassau Bay: MD Anderson in the Bay Area
    • Contact: Banu Arun, MD by email
  • Texas, Sugar Land: MD Anderson Sugar Land   
  • Texas, The Woodlands: MD Anderson - The Woodlands  
    • Contact: Banu Arun, MD by email 

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