Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 2012
End Date:October 2021

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

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.

If screening tests show that you are eligible to participate in the research study you will
begin study treatment. You may undergo an optional 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

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

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 DF/HCC. 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

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.

Inclusion Criteria:

- Pathologic confirmation of invasive breast cancer

- Stage: Clinical T1 >/= 1.0 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 anthracycline or platinum based therapy

- 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
We found this trial at
330 Brookline Ave
Boston, Massachusetts 02215
Principal Investigator: Nadine Tung, MD
Phone: 617-667-7081
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Steven Isakoff, MD, PhD
Phone: 617-726-4920
Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Durham, NC
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Aurora, Colorado 80045
Phone: 303-724-0186
Aurora, CO
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
Principal Investigator: Judy Garber, MD, MPH
Phone: 617-632-2282
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Boston, MA
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350 Seymour Avenue
Derby, Connecticut 06418
Derby, CT
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111 Goose Lane
Guilford, Connecticut 06437
Guilford, CT
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Hartford, Connecticut 06105
Hartford, CT
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Houston, Texas 77030
Phone: 713-792-2817
Houston, TX
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New Brunswick, New Jersey 08903
Phone: 732-235-6789
New Brunswick, NJ
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New Haven, Connecticut 06520
Phone: 203-737-1600
New Haven, CT
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Providence, Rhode Island 02905
Phone: 401-453-7540
Providence, RI
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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