Clinical Trials /

Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa

NCT01670500

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Cisplatin</span> vs. <span class="go-doc-concept go-doc-intervention">Doxorubicin/Cyclophosphamide</span> in BrCa

Title

  • Brief Title: Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
  • 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
  • Clinical Trial IDs

    NCT ID: NCT01670500

    ORG ID: 12-258

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin cisplatinum, or cis-diamminedichloroplatinum(II) (CDDP) Cisplatin
    Cyclophosphamide Cytoxan Doxorubicin-Cyclophosphamide
    Doxorubicin Adriamycin Doxorubicin-Cyclophosphamide

    Trial Purpose

    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.

    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.

    Trial Arms

    Name Type Description Interventions
    Doxorubicin-Cyclophosphamide Active Comparator Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4 Cyclophosphamide, Doxorubicin
    Cisplatin Active Comparator Cisplatin q 3 wk x 4 Cisplatin

    Eligibility 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    pCR to neoadjuvant cisplatin vs. pCR to AC

    Secondary Outcome Measures

    Residual Cancer Burden after neoadjuvant cisplatin or AC

    Clinical response rate

    Comparison of toxicities of cisplatin and AC

    Collection of pre-chemotherapy biopsies

    Trial Keywords

    germline mutation

    BRCA1 mutation

    BRCA2 mutation