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Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Cisplatin (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Nadine Tung, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Overall contact:
Nadine Tung, MD, Phone: 6176677081, Email: ntung@bidmc.harvard.edu

Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.

Clinical Details

Official title: A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pCR to neoadjuvant cisplatin vs. pCR to AC

Secondary outcome:

Residual Cancer Burden after neoadjuvant cisplatin or AC

Clinical response rate

Comparison of toxicities of cisplatin and AC

Collection of pre-chemotherapy biopsies

Detailed description: If screening tests show that you are eligible to participate in the research study you will begin study treatment. You will undergo a research biopsy so the study team can obtain tissue samples. This will be used for biomarker research and will help your doctors to better understand your disease, how the drug is working in your body, and may help to identify which people may benefit most from platinum or from adriamycin/cytoxan in the future. Because no one knows which of the study options is best, you will be "randomized" to receive either cisplatin or doxorubicin and cyclophosphamide ("AC") chemotherapy prior to removal of your breast cancer. Chemotherapy administered before the removal of the cancer is known as neoadjuvant chemotherapy. Randomization means that you are put into a group by chance. It is like flipping a coin. 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. If you are randomized to receive cisplatin you will receive cisplatin once every three weeks for a total of four doses. You will be given cisplatin by vein (IV) on the first day of each treatment cycle. The cisplatin infusion can take between 1 to 2 hours. Before and after receiving cisplatin, you will receive fluid hydration by vein, and you will also be given medicine to help prevent side effects such as nausea. The total time of the infusion of cisplatin and the additional fluid and medications will take about 6 hours. After you receive cisplatin, you will be asked to drink about 12 eight ounce glasses of fluid per day, especially 2 or 3 days after therapy. The study treatment will stop if you have serious side effects or if the tumor grows despite receiving cisplatin chemotherapy. If you are randomized to "AC" chemotherapy you 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. The interval between chemotherapy will be decided by your research doctor. If you receive the chemotherapy every two weeks, you will also receive a subcutaneous injection the day after chemotherapy. This injection contains a medicine that contains a growth factor that will boost your immune system in order to allow your body to be ready for chemotherapy in two weeks. The study treatment will be stopped if you have serious side effects or if the tumor grows despite the doxorubicin and cyclophosphamide chemotherapy. At the beginning of each treatment cycle you will have a physical exam (including weight and vital signs) and you will be asked general questions about your health and any medications you may be taking, as well as specific questions about any side effects you may be experiencing while receiving study treatment. Prior to each cycle of chemotherapy, you will have standard blood tests to check your blood counts. If you are receiving cisplatin your kidney function and body salts will also be checked prior to each chemotherapy cycle. In addition, 7-10 days after chemotherapy your blood will be drawn to look at your blood cell count to determine your risk of infection; if you have received cisplatin, your kidney function and blood electrolytes will also be evaluated. The blood draw performed 7-10 days after chemotherapy can be done in the hospital where you received your chemotherapy or closer to home. About 1 tablespoon of blood will be drawn for these tests. Surgery to remove your tumor will occur within six weeks after the last dose of chemotherapy. Your surgery will be performed by your surgeon, as part of the standard care for your disease. Your treating physician or nurse practitioner will examine you to assess your tumor each time you receive chemotherapy. A measurement of your tumor will be performed on the first day of each treatment cycle as part of your physical exam. After the slides of your initial breast cancer biopsy have been reviewed at your hospital, these slides and your tumor block will be sent to the study pathologist at Beth Israel Deaconess Medical Center. Likewise, after chemotherapy, your breast cancer will be removed by lumpectomy or mastectomy. After these slides are reviewed at your hospital, they will also be sent with the tumor block to the study pathologist so that the response of your tumor to the study treatment can be assessed. After these slides are reviewed, they will be returned to the hospital at which the biopsy and surgery were performed. Decisions about whether you will receive more chemotherapy after your surgery is up to your treating physicians. If you receive chemotherapy, the choice of chemotherapy is also up to your doctors. Decisions about post-operative chemotherapy are not part of this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pathologic confirmation of invasive breast cancer

- Stage: Clinical T1 >/= 1. 5 cm, T2 or T3, N0-3, M0

- HER2 negative

- ER and PgR status by immunohistochemistry must be known. ER positive patients are

allowed if physicain has determined neoadjuvant chemo is appropriate.

- Life expectancy greater than six months

- Use of an effective means of contraception is required

Exclusion Criteria:

- Pregnant or breastfeeding

- Prior chemotherapy at any time

- Prior treatment for the current breast cancer, including chemotherapy, hormonal

therapy, radiation or experimental therapy

- Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for

DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer

- Peripheral neuropathy of any etiology that exceeds grade 1

- Significant hearing loss

- Renal dysfunction

- Use of other investigational or study agents

- History of allergic reactions attributed to compounds of similar chemical or biologic

composition to study drugs

- Uncontrolled intercurrent illness

- Any condition that would prohibit administration of corticosteroids

- Uncontrolled diabetes

- Pre-existing medical condition that would represent toxicity in excess of grade 1 as

measured by CTCAE (unless not considered medically significant by the physician)

- Known HIV positive individuals on combination antiretroviral therapy

Locations and Contacts

Nadine Tung, MD, Phone: 6176677081, Email: ntung@bidmc.harvard.edu

Cedars Sinai Hospital, Los Angeles, California 90048, United States; Recruiting
William Audeh, MD, Phone: 310-423-1188, Email: william.audeh@cshs.org

University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Recruiting
Virginia Borges, MD, Phone: 303-724-0186, Email: virginia.borges@ucdenver.edu

Yale School of Medicine, New Haven, Connecticut 06520, United States; Recruiting
Erin Hofstatter, MD, Phone: 203-737-1600, Email: erin.hofstatter@yale.edu

Georgetown University Medical Center, Washington D.C., District of Columbia 20007, United States; Recruiting
Claudine Isaacs, MD, Email: isaacsc@georgetown.edu

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Nadine Tung, MD, Phone: 617-667-7081, Email: ntung@bidmc.harvard.edu
Nadine Tung, MD, Principal Investigator

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States; Recruiting
Judy Garber, MD, MPH, Phone: 617-632-2282, Email: jegarber@partners.org
Judy Garber, MD, MPH, Principal Investigator

Dana-Farber Cancer Institute at Faulkner Hospital, Boston, Massachusetts 02130, United States; Withdrawn

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Steven Isakoff, MD, PhD, Phone: 617-726-4920, Email: sisakoff@partners.org
Steven Isakoff, MD, PhD, Principal Investigator

New Hampshire Oncology-Hematology, Hooksett, New Hampshire 03106, United States; Recruiting
Douglas Weckstein, MD, Phone: 603-622-6484, Email: d.weckstein@nhoh.com

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States; Recruiting
Deborah Toppmeyer, MD, Phone: 732-235-6789, Email: toppmede@umdnj.edu

Memorial Sloan-Kettering Cancer Center, NY, New York 10065, United States; Not yet recruiting
Mark Robson, MD, Phone: 646-888-4058, Email: robsonm@mskcc.org

University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Susan Domchek, MD, Phone: 215-615-3360, Email: susan.domchek@uphs.upenn.edu

Women and Infants Hospital, Providence, Rhode Island 02905, United States; Recruiting
Robert Legare, MD, Phone: 401-453-7540, Email: rlegare@wihri.org

MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Banu Arun, MD, Phone: 713-792-2817, Email: barun@mdanderson.org

Additional Information

Starting date: October 2012
Last updated: April 27, 2015

Page last updated: August 23, 2015

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