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 ACClinical 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
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